MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US UNKNOWN HIP FEMORAL HEAD

Catalog Number UNK HIP FEMORAL HEAD

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Foreign Body Reaction (1868); Pain (1994); Injury (2348); No Code Available (3191)

Event Date 10/01/2019

Event Type  Injury  

Manufacturer Narrative

(b)(4). Initial reporter occupation: lawyer. If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

Event Description

It was reported that the patient was a receiver of 2 pinnacle hip implants. He is scheduled for surgery on his left hip in 2 weeks and on the right hip after recovery. Patient is willing to make settlement. Doi: unknown; dor: unknown (left hip). Please see (b)(4) for the right hip.

Manufacturer Narrative

Product complaint # (b)(4). Investigation summary: no device associated with this report was received for examination. A worldwide lot specific complaint database search, or manufacturing record evaluation, was not possible as the required lot number was not provided. The information received will be retained for trend analysis, post market surveillance, or other events within the quality system. H10 additional narrative: added: h6 (patient). H6 patient code: no code available (3191) was used to capture emotional distress and device revision or replacement.

Event Description

Litigation records received. In additional to what were previously reported, litigation record alleges metallosis, pain, injury, emotional distress, disability and disfigurement.

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

• Brand Name: UNKNOWN HIP FEMORAL HEAD
• Type of Device: HIP FEMORAL HEAD
• Manufacturer (Section D): DEPUY ORTHOPAEDICS INC US; 700 orthopaedic drive; warsaw IN 46581 0988
• MDR Report Key: 9837071
• Report Number: 1818910-2020-08016
• 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,other
• Type of Report: Initial,Followup,Followup
• Report Date: 10/16/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/16/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No

Device Operator

• Device Catalogue Number: UNK HIP FEMORAL HEAD
• Was Device Available for Evaluation?: No

Was the Report Sent to FDA?

• Event Location: No Information
• Date Manufacturer Received: 07/08/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Outcome(s): Required Intervention