MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US S-ROM M HEAD 36MM +0; HIP FEMORAL HEAD

Catalog Number 136531000

Device Problems Material Disintegration (1177); Appropriate Term/Code Not Available (3191)

Patient Problems Host-Tissue Reaction (1297); Pain (1994); Tissue Damage (2104); Limited Mobility Of The Implanted Joint (2671)

Event Date 01/09/2015

Event Type  Injury  

Event Description

Patient was revised to address pain, elevation ion levels, large fluid collection and pseudotumor.Update rec¿d 01/09/2015 - patient's medical records were received.Medical records were reviewed for mdr reportability.There is no additional information to report at this time.The complaint was updated on: 01/28/2015.

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.(b)(4).

Manufacturer Narrative

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 insert.Per procedure, this device(s) is exempt from device history record review.A search of the complaints databases identified no other reports against the remaining product/lot code combinations.Review of provided patient x-rays confirms the reported event.The investigation can draw no further conclusions 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

(b)(4).Added: patient and device code.

Event Description

After review of medical records, patient was revised to address failed metal-on-metal bearing, secondary to wear.Intraoperative findings stated that there was a metal-tinged synovial sac present extending from the joint posteriorly and encompassing the entire lining of the joint.Fluid present was dark-tinged fluid consistent with a metallosis and there was trunnionosis present with some black chalky debris at the trunnion.Clinical notes reported of decreasing mobility.

Manufacturer Narrative

Depuy synthese is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on information which depuy synthese has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy synthese or its employees that the report constitutes an admission that the device, depuy synthese, 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 pain, elevation ion levels, large fluid collection and pseudotumor.Update rec¿d (b)(6) 2015 - patient's medical records were received.Medical records were reviewed for mdr reportability.There is no additional information to report at this time.The complaint was updated on: (b)(6) 2015 update (b)(6) 2017.Litigation received.In addition to what was previously reported, litigation now alleges increased rehabilitation.There is no new information that would change the mdr reportability.This complaint was updated on (b)(6) 2017./ | investigation method: no devices to review.Attached radiographs and photographs were reviewed (b)(6) 2015.There was no evidence of implant fracture or implant disassociation.Ap and lateral radiographs dated 16 sep 2014 reveal bilateral uncemented total hip arthroplasties.The left hip implants appear to be of appropriate size and position with no evidence of loosening.The leg lengths are radiographically equal.The photograph is of a black ¿stained tissue/pseudotumor suggestive of metal debris /metallosis that confirms the complaint.A search of the complaints databases identified other reports against the insert and femoral head.Per procedure wi-3430, this device(s) is exempt from device history record review.A search of the complaints databases identified no other reports against the remaining product/lot code combinations.Based on the inability to find any other reported incidents against the provided product and lot code combinations, 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 further conclusions with the information provided./ | investigation summary: patient was revised to address pain, elevation ion levels, large fluid collection and pseudotumor.Update rec¿d (b)(6) 2015 - patient's medical records were received.Medical records were reviewed for mdr reportability.There is no additional information to report at this time.The complaint was updated on: (b)(6) 2015 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 insert.Per procedure, this device(s) is exempt from device history record review.A search of the complaints databases identified no other reports against the remaining product/lot code combinations.Review of provided patient x-rays confirms the reported event.The investigation can draw no further conclusions with the information provided.Based on the inability to determine root cause, the need for corrective action has not been indicated.

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.H10 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.If information is obtained that was not available for the initial medwatch, a follow-up medwatch, a follow-up medwatch will be filed as appropriate.

• Brand Name: S-ROM M HEAD 36MM +0
• Type of Device: HIP FEMORAL HEAD
• Manufacturer (Section D): DEPUY ORTHOPAEDICS INC US; 700 orthopaedic drive; warsaw IN 46582 0988
• MDR Report Key: 4474426
• MDR Text Key: 5404180
• Report Number: 1818910-2015-12382
• Device Sequence Number: 1
• Product Code: LPH
• Combination Product (y/n): N
• PMA/PMN Number: PK120599
• 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
• Report Date: 01/09/2015

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: 04/04/2011
• Device Catalogue Number: 136531000
• Device Lot Number: 2139956
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 01/09/2015
• Initial Date FDA Received: 02/02/2015
• Supplement Dates Manufacturer Received: 08/13/2018; 11/12/2018; 07/23/2019
• Supplement Dates FDA Received: 08/13/2018; 11/14/2018; 07/23/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 73 YR
• Patient Weight: 82