MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US UNKNOWN HIP FEMORAL STEM; HIP FEMORAL STEM/SLEEVE

Catalog Number UNK HIP FEMORAL STEM

Device Problems Loss of Osseointegration (2408); Osseointegration Problem (3003)

Patient Problems Host-Tissue Reaction (1297); Irritation (1941); Pain (1994); Swelling (2091); Tissue Damage (2104); Joint Disorder (2373); Test Result (2695); No Information (3190); No Code Available (3191)

Event Date 10/27/2016

Event Type  Injury  

Manufacturer 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.Follow-up with the complainant has been conducted for the catalog number and lot number and this information is not available.

Event Description

Patient was revised due to femoral stem loosening.The stem was in varus and undersized.Per surgeon the patient also had elevated ion levels.

Manufacturer Narrative

This complaint is still under investigation.Depuy will notify the fda of the results of this investigation once it has been completed.

Event Description

Update rec¿d 11/22/2016 - litigation papers received.In addition to what was previously reported, litigation also alleges the patient suffers from pain.Date of implant was provided.

Manufacturer Narrative

No device associated with this report was received for examination.A worldwide lot specific complaint database search, or device history record (dhr) review was not possible because the required lot code(s) was not provided.Based on previous investigations this complication of joint replacement is unlikely to have been the result of a device failing to meet required specifications.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.Corrective action was not indicated.Depuy considers the investigation closed.Should additional information be received, the information will be reviewed and the investigation will be re-opened as necessary.

Manufacturer Narrative

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

Event Description

Update 04/17/2017.Pfs and medical records received.Medical records stated pain, increase metal ions (no laboratories), stem loosening, slight anteversion of acetabular shell, slight impingement.Added an attorney in complainant information and an unknown depuy acetabular cup in product information.The complaint was updated on: apr 25, 2017.

Manufacturer Narrative

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

Event Description

Update may 22, 2017: legal medical records received.After review of the medical records for the mdr reportability, patient had an uncemented right total hip arthroplasty.Bone scan showed an early loosening of femoral component.Mri showed some swelling in the pseudocapsule which was likely a small pseudotumor.It was also stated that patient does have some gluteal tendon irritation.Physical therapy notes stated patient also experience hip bursitis.Laboratory values for chromium-cobalt level were above 7ppb.It was also reported in the intraoperative notes that various moreland set was used, in removing of the sleeve , and one of the tip of the instruments was broke off and left in patient.This complaint was updated on may 30, 2017.

Manufacturer Narrative

Depuy synthes is submitting this report pursuant to the provision of 21 cfr, part 803.The report may be based on the 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.Product complaint # (b)(4).Investigation summary : the device associated with this report was not returned for examination.Depuy synthes considers the investigation closed at this time.Should additional information be received, the information will be reviewed and the investigation may be re-opened as necessary.No device associated with this report was received for examination.A worldwide lot specific complaint database search, or device history record (dhr) review was not possible because the required lot code(s) was not provided.Based on previous investigations this complication of joint replacement is unlikely to have been the result of a device failing to meet required specifications.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.Corrective action was not indicated.The reported event is considered one of the possible complications of joint replacement.Investigational inputs were requested as indicated per internal procedures for this failure mode.The complaint information provided has been reviewed for complaint coding, medical device reporting, and other data required by the complaint system.Follow-up for additional event information, if applicable, was conducted utilizing work instruction (b)(4).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.No information received with this individual complaint indicated that a broader investigation or corrective action was necessary.Device history lot : null.Device history batch : null.Device history review : null.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.  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 : null device history batch : null device history review : 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 due to femoral stem loosening.The stem was in varus and undersized.Per surgeon the patient also had elevated ion levels.Update rec¿d (b)(6) 2016 - litigation papers received.In addition to what was previously reported, litigation also alleges the patient suffers from pain.Date of implant was provided.There is no new information that would change the existing mdr decision.Complaint was updated (b)(6) 2016 update 04/17/2017.Pfs and medical records received.Medical records stated pain, increase metal ions (no laboratories), stem loosening, slight anteversion of acetabular cup, slight impingement.Added an attorney in complainant information and an unknown depuy acetabular cup in product information.The complaint was updated on: apr 25, 2017 update may 22, 2017: legal medical records received.After review of the medical records for the mdr reportability, patient had an uncemented right total hip arthroplasty.Bone scan showed an early loosening of femoral component.Mri showed some swelling in the pseudocapsule which was likely a small pseudotumor.It was also stated that patient does have some gluteal tendon irritation.Physical therapy notes stated patient also experience hip bursitis.Laboratory values for chromium-cobalt level were above 7ppb.It was also reported in the intraoperative notes that various moreland set was used, in removing of the sleeve , and one of the tip of the instruments was broke off and left in patient.This complaint was updated on may 30, 2017./ | investigation method: no device associated with this report was received for examination.A worldwide lot specific complaint database search, or device history record (dhr) review, was not possible because the required lot code(s) was not provided.The reported event is considered one of the possible complications of joint replacement.The complaint information provided has been reviewed for complaint coding, medical device reporting, and other data required by the complaint system.Follow-up for additional event information, if applicable, was conducted utilizing work instruction wi-7915 appendix a.- 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.Xrays were reviewed.No implant fracture or disassociation noted.The stem does appear to be in a less than optimal position.It is unknown what position the stem was originally in as there were no progressive x-rays provided./ | investigation summary: patient was revised due to femoral stem loosening.The stem was in varus and undersized.Per surgeon the patient also had elevated ion levels.Update rec¿d 11/22/2016 - litigation papers received.In addition to what was previously reported, litigation also alleges the patient suffers from pain.Doi: (b)(6) 2010 - dor: (b)(6) 2016 (right hip) no device associated with this report was received for examination.A worldwide lot specific complaint database search, or device history record (dhr) review was not possible because the required lot code(s) was not provided.Based on previous investigations this complication of joint replacement is unlikely to have been the result of a device failing to meet required specifications.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.Corrective action was not indicated.

• Brand Name: UNKNOWN HIP FEMORAL STEM
• Type of Device: HIP FEMORAL STEM/SLEEVE
• Manufacturer (Section D): DEPUY ORTHOPAEDICS INC US; 700 orthopaedic drive; warsaw IN 46582 0988
• MDR Report Key: 6081243
• MDR Text Key: 59278482
• Report Number: 1818910-2016-30939
• Device Sequence Number: 1
• Product Code: KWY
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,distributor,health p
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date: 10/28/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/07/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: UNK HIP FEMORAL STEM
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 12/10/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 53 YR
• Patient Weight: 104