MAUDE Adverse Event Report: DEPUY ORTTHOPAEDICS INC US S-ROM*SLEEVE PRX ZTT, 16B-SML; HIP FEMORAL STEM/SLEEVE

Catalog Number 521463

Device Problems Adverse Event Without Identified Device or Use Problem (2993); Appropriate Term/Code Not Available (3191)

Patient Problems Host-Tissue Reaction (1297); Foreign Body Reaction (1868); Necrosis (1971); Pain (1994); Swelling (2091); Tissue Damage (2104); Discomfort (2330); Osteolysis (2377); No Code Available (3191)

Event Date 05/25/2016

Event Type  Injury  

Manufacturer Narrative

(b)(4).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.

Event Description

Patient was revised to address osteolysis and edge loading of the acetabular liner, which was not seated properly.Update rec'd 12/14/2016 litigation papers received.In addition to what was previously reported, litigation also alleges the patient suffers from pain, popping, clicking, squeaking, discomfort, swelling, metallosis and elevated ions levels.An invoice was found providing part and lot numbers.Adding the femoral stem and sleeve to the complaint for the elevated ions.

Manufacturer Narrative

Additional narrative: examination of the reported devices was not possible as they were not returned.A search of the complaints databases finds no other reports against the product and lot code combinations since their release to distribution.The investigation can draw no conclusion with the information provided.Based on the inability to determine root cause, the need for corrective action has not been 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 still considers the investigation closed.Should additional information be received, the information will be reviewed and the investigation will be re-opened as necessary.

Event Description

Update 03/07/17 (pfs-390) pfs and medical records received.Plaintiff alleges constant hip pain, inability to walk more than 10 feet, ride in a car, or stand or sit for more than 5 minutes, and loss of bone and muscle.Revising surgeon identified a "large mass 6 x 3 x 7 cm.Invading the outside of hip joint, abductors, and greater trochanter".Also, "severe metallosis was encountered".There was "mild corrosion was noted at the taper".The "femoral component was well-fixed with severe osteolysis on the proximal bone-metal interface" and a "significant amount of necrotic bone" was debrided."some metal wear was noted" in the acetabular liner.Acetabular cup was well-fixed.

Event Description

Ppf alleges pseudotumor, abductor muscle repair, metal wear, metallosis and elevated metal ions, however metallosis and elevated metal ions were already reported.

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. udi: (b)(4).

Manufacturer Narrative

Product complaint # (b)(4).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.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.In order to determine if a lot related issue was possible, a worldwide complaint database search was performed.A worldwide complaint database search found no additional related reports against the provided product code/lot code combination.Based on the inability to find any additional related reports against the provided product code/lot code combination it is reasonable to conclude that there are no anomalies with regard to manufacturing or inspection contained in the device history records that would contribute to the reported event.Per nr-0134037 a medical record review is not required for this complaint record.A review of the medical records was performed as part of the previous investigation.Please see the attached associated complaint for those results.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 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.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.

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 to address osteolysis and edge loading of the acetabular liner, which was not seated properly.Update rec'd 12/14/2016 litigation papers received.In addition to what was previously reported, litigation also alleges the patient suffers from pain, popping, clicking, squeaking, discomfort, swelling, metallosis and elevated ions levels.An invoice was found providing part and lot numbers.Adding the femoral stem and sleeve to the complaint for the elevated ions.Complaint was updated 12/16/2016.Update 03/07/2017 (pfs-390) pfs and medical records received.Plaintiff alleges constant hip pain, inability to walk more than 10 feet, ride in a car, or stand or sit for more than 5 minutes, and loss of bone and muscle.Revising surgeon identified a "large mass 6 x 3 x 7 cm invading the outside of hip joint, abductors, and greater trochanter".Also, "severe metallosis was encountered".There was "mild corrosion was noted at the taper".The "femoral component was well-fixed with severe osteolysis on the proximal bone-metal interface" and a "significant amount of necrotic bone" was debrided."some metal wear was noted" in the acetabular liner.Acetabular cup was well-fixed.No new information available to change the existing mdr decision.The complaint was updated on: 3/27/2017.

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

• Type of Device: HIP FEMORAL STEM/SLEEVE
• Manufacturer (Section D): DEPUY ORTTHOPAEDICS INC US; 700 orthopaedic drive; warsaw IN 46581 0988
• MDR Report Key: 6180346
• MDR Text Key: 62527341
• Report Number: 1818910-2016-33540
• Device Sequence Number: 1
• Product Code: MRA
• Combination Product (y/n): N
• PMA/PMN Number: P070026
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,other
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date: 12/14/2016

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: 02/28/2015
• Device Catalogue Number: 521463
• Device Lot Number: 3094542
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 12/14/2016
• Initial Date FDA Received: 12/16/2016
• Supplement Dates Manufacturer Received: Not provided; Not provided; 06/27/2018; 03/28/2019; 11/06/2019; 01/06/2020
• Supplement Dates FDA Received: 02/03/2017; 03/27/2017; 07/27/2018; 04/18/2019; 11/14/2019; 01/06/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 68 YR
• Patient Weight: 57