MAUDE Adverse Event Report: DEPUY ORTHOPAEDIC INC, 1818910 S-ROM M HEAD 36MM +3; HIP FEMORAL HEAD

Catalog Number 136532000

Device Problems Corroded (1131); Appropriate Term/Code Not Available (3191)

Patient Problems Cyst(s) (1800); Foreign Body Reaction (1868); Inflammation (1932); Muscular Rigidity (1968); Pain (1994); Loss of Range of Motion (2032); Skin Irritation (2076); Synovitis (2094); Tissue Damage (2104); Discomfort (2330); Joint Swelling (2356); Osteolysis (2377); Limited Mobility Of The Implanted Joint (2671)

Event Date 12/17/2014

Event Type  Injury  

Event Description

Patient was revised to address osteolysis.Upon revision corrosion was noted.Update rec¿d 12/17/2014 - patient's medical records were received.Medical records were reviewed for mdr reportability.At this time there is no additional information to report.The complaint was updated on: 01/12/2015.

Manufacturer Narrative

Additional narrative: this complaint is still under investigation.Depuy will notify the fda of the results of this investigation once it has been completed.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.(b)(4).Follow-up with the complainant has been conducted for the lot number and this information is not available.

Manufacturer Narrative

If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

Manufacturer Narrative

The devices associated with this report were not returned.Based on previous investigations this complication of joint replacement is unlikely to have been the result of a device failing to meet required specifications.Requests for additional investigational inputs were made in accordance with wi-7915 appendix a.No additional information was obtained.The investigation could not verify or identify any product contribution to the reported event with the information provided.Based on the inability to identify root cause, the need for corrective action was not indicated.Depuy considers the investigation closed at this time.Should additional information be received, the information will be reviewed and the investigation will be re-opened as necessary.

Manufacturer Narrative

Depuy considers the investigation closed at this time.Should additional information be received, the information will be reviewed and the investigation will be re-opened as necessary.

Event Description

Update rec'd 1/18/2016: litigation received.Litigation also alleges pain, discomfort, elevated metal ions, and inflammation.There is no new information that would change the existing invesigation.This complaint was updated on:1/25/2016.

Manufacturer Narrative

Depuy still considers this investigation closed at this time.

Event Description

Update 4/8/16- pfs and medical records received.Pfs and medical records reviewed for mdr reportability.Pfs reported pain and suffering, revision surgery, decreased range of motion, decreased mobility, increased risk of dislocation and additional revision surgeries, metal toxicity and a spontaneous fracture of left hip in 2014.Medical records reported that patient had morning stiffness, neck pain, right posterior thigh pain and on x-ray reportedly there was a minimal amount of calcification at tip of greater trochanter.Revision surgical records reported cystic erosion changes, significant effusion, foreign body synovitis with brown and black staining, corrosion, and osteolysis in bilateral hips.Pathology reports noted chronic inflammation and chronic metallosis from bilateral hip tissue.There were no metal ion lab result reports within medical records reviewed at this time.There is no new additional information that would affect the existing investigation.The complaint was updated on: apr 27, 2016.

Manufacturer Narrative

(b)(4).Investigation summary: no device associated with this report was received for examination.The information received will be retained for potential series investigations if triggered by trend analysis, post market surveillance, or other events within the quality system.Depuy considers the investigation closed.Should additional information be received, the information will be reviewed and the investigation will be re-opened as necessary.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

Manufacturer Narrative

Depuy synthes is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on information which depuy synthes has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy synthes or its employees that the report constitutes an admission that the device, depuy synthes, or its employees caused or contributed to the potential event described in this report.  additional narrative: product complaint # (b)(4).Investigation summary no device associated with this report was received for examination.The information received will be retained for potential series investigations if triggered by trend analysis, post market surveillance, or other events within the quality system.Depuy considers the investigation closed.Should additional information be received, the information will be reviewed and the investigation will be re-opened as necessary.Device history lot
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> null.Device history batch
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> null.Device history review
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> null.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

Event Description

Complaint description: patient was revised to address osteolysis.Upon revision corrosion was noted.Update rec¿d 12/17/2014 - patient's medical records were received.Medical records were reviewed for mdr reportability.At this time there is no additional information to report.The complaint was updated on: (b)(6) 2015 update rec¿d 01/16/2015- clinical der received.Metalloids and adverse tissue reaction were noted.The complaint was updated: (b)(6) 2015 update rec'd 1/18/2016: litigation received.Litigation also alleges pain, discomfort, elevated metal ions, and inflammation.There is no new information that would change the existing investigation.This complaint was updated on: (b)(6) 2016 update 4/8/16- pfs and medical records received.Pfs and medical records reviewed for mdr reportability.Pfs reported pain and suffering, revision surgery, decreased range of motion, decreased mobility, increased risk of dislocation and additional revision surgeries, metal toxicity and a spontaneous fracture of left hip in 2014.Medical records reported that patient had morning stiffness, neck pain, right posterior thigh pain and on x-ray reportedly there was a minimal amount of calcification at tip of greater trochanter.Revision surgical records reported cystic erosion changes, significant effusion, foreign body synovitis with brown and black staining, corrosion, and osteolysis in bilateral hips.Pathology reports noted chronic inflammation and chronic metallosis from bilateral hip tissue.There were no metal ion lab result reports within medical records reviewed at this time.There is no new additional information that would affect the existing investigation.The complaint was updated on: (b)(6) 2016 update 03/01/2017 medical records received.After review of the medical records for mdr reportability, there was no new information that would affect the existing mdr investigation.There were several blacked out pictures provided in the medical records that were too dark to be analyzed.The complaint was updated on: (b)(6) 2017 / | investigation method: the devices associated with this report were not returned.In order to determine if a lot related issue was possible, a worldwide complaint database search was performed.A complaint database search did find additional related reports against the provided product code and lot number combination(s).However; a review of the device history record(s) associated with this complaint was not required per (b)(4).Requests for additional investigational inputs were made in accordance with (b)(4) appendix a.No additional information was obtained.- without the physical complaint sample(s) associated with this report, it was not possible to determine if the device(s) failed to meet specification(s) at the time it was released for distribution.- the device(s) associated with this event were used in the treatment of the patient as prescribed by the presiding surgeon.- from the event information received, it was not possible to determine the relationship of the device to the reported event.The patient was reported as a 69 year old male with a height of 5 feet 9 inches and weight of 235 pounds.Medical record review**** (b)(6) 2015, see attached for full review.**** no implant fracture or disassociation noted.Patient is bilateral.Examination of the reported devices was not possible as they were not returned.A search of the complaints databases identified other reports against the femoral head and/or liner.Per procedure, this device is exempt from device history record review.A search of the complaints databases identified no other reports against the remaining product/lot code combination.Based on the inability to find any other reported incidents against the provided product and lot code combination, it is not unreasonable to conclude that there are no anomalies with regard to manufacturing, inspection or sterilization contained in the device history records that would contribute to the reported event.The investigation can draw no conclusions with the information provided.(b)(6) 2017 xrays no implant fracture or disassociation noted.Medical records need reviewed medical records reviewed (b)(6) 2017 kbr there was no new information obtained within the provided additional information that changed the outcome of the previous investigation and medical record review./ | investigation summary: patient was revised to address osteolysis.Upon revision corrosion was noted.Update rec¿d 12/17/2014 - patient's medical records were received.Medical records were reviewed for mdr reportability.At this time there is no additional information to report.Update rec¿d 01/16/2015- clinical der received.Metalloids and adverse tissue reaction were noted.Doi: (b)(6) 2006 - dor: (b)(6) 2014 (right hip) the devices associated with this report were not returned.Based on previous investigations this complication of joint replacement is unlikely to have been the result of a device failing to meet required specifications.Requests for additional investigational inputs were made in accordance with (b)(4) appendix a.No additional information was obtained.The investigation could not verify or identify any product contribution to the reported event with the information provided.Based on the inability to identify root cause, the need for corrective action was not indicated.Update 4/8/16- pfs and medical records received.Pfs and medical records reviewed for mdr reportability.Pfs reported pain and suffering, revision surgery, decreased range of motion, decreased mobility, increased risk of dislocation and additional revision surgeries, metal toxicity and a spontaneous fracture of left hip in 2014.Medical records reported that patient had morning stiffness, neck pain, right posterior thigh pain and on x-ray reportedly there was a minimal amount of calcification at tip of greater trochanter.Revision surgical records reported cystic erosion changes, significant effusion, foreign body synovitis with brown and black staining, corrosion, and osteolysis in bilateral hips.Pathology reports noted chronic inflammation and chronic metallosis from bilateral hip tissue.There were no metal ion lab result reports within medical records reviewed at this time.There is no new additional information that would affect the existing investigation.Examination of the reported devices was not possible as they were not returned.A search of the complaints databases identified other reports against the femoral head and/or liner.Per procedure, this device is exempt from device history record review.A search of the complaints databases identified no other reports against the remaining product/lot code combination.Xrays and medical records were reviewed.The investigation can draw no conclusions with the information provided.Based on the inability to determine root cause, the need for corrective action has not been indicated.

• Brand Name: S-ROM M HEAD 36MM +3
• Type of Device: HIP FEMORAL HEAD
• Manufacturer (Section D): DEPUY ORTHOPAEDIC INC, 1818910; . 700 orthopaedic drive; warsaw IN 46582 0988
• MDR Report Key: 4413354
• MDR Text Key: 5373194
• Report Number: 1818910-2015-10920
• Device Sequence Number: 1
• Product Code: LPH
• Combination Product (y/n): N
• PMA/PMN Number: PK851422
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Distributor,consumer,distributor,he
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date: 12/17/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 08/24/2010
• Device Catalogue Number: 136532000
• Device Lot Number: 1951106
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 05/12/2015
• Initial Date FDA Received: 01/13/2015
• Supplement Dates Manufacturer Received: Not provided; Not provided; Not provided; Not provided; 05/31/2018; 05/31/2018
• Supplement Dates FDA Received: 02/09/2015; 05/14/2015; 03/01/2016; 04/27/2016; 06/01/2018; 06/01/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 69 YR
• Patient Weight: 107