MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US UNKNOWN DEPUY PINNACLE METAL LINER HIP ACETABULAR INSERT/LINER

Catalog Number 121887354

Device Problems Insufficient Information (3190); Noise, Audible (3273)

Patient Problems Foreign Body Reaction (1868); Pain (1994); Swelling (2091); Discomfort (2330)

Event Date 08/25/2016

Event Type  Injury  

Manufacturer Narrative

Udi: (b)(4).

Manufacturer Narrative

This complaint is the subject of litigation or a legal claim and currently complete product detail is not available at this time. A follow-up medwatch will be filed as appropriate. 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

Litigation states patient was revised to address pain, discomfort and swelling.

Manufacturer Narrative

Examination of the reported devices was not possible as they were not returned. A search of the complaints databases and/or a review of device history records were not possible as the required product/lot code combinations were not provided. The investigation can draw no conclusion regarding the reported event with the information available. 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).

Event Description

Update ((b)(4)) pfs and medical records received. Pfs alleges pain, elevated levels of chromium and cobalt and struggled with occasional limited mobility. It was also stated that there was a crunching sound in left hip. No laboratory values provided. The complaint was updated on apr 28, 2017.

• Brand Name: UNKNOWN DEPUY PINNACLE METAL LINER
• Type of Device: HIP ACETABULAR INSERT/LINER
• Manufacturer (Section D): DEPUY ORTHOPAEDICS INC US; 700 orthopaedic drive; warsaw IN 46581 0988
• Manufacturer (Section G): LEEDS MFG & MATERIAL WAREHOUSE; st anthonys road; leeds LS11 8 DT; UK LS11 8 DT
• Manufacturer Contact: chad gibson ; 700 orthopaedic drive; warsaw, IN 46581-0988 ; 5743725905
• MDR Report Key: 6270859
• MDR Text Key: 132638219
• Report Number: 1818910-2017-11230
• Device Sequence Number: 1
• Product Code: KWY
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer
• Reporter Occupation: Attorney
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date: 01/18/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/23/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No

Device Operator

• Device Expiration Date: 04/01/2011
• Device Catalogue Number: 121887354
• Device Lot Number: 2138003
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No

Was the Report Sent to FDA?

• Event Location: No Information
• Date Manufacturer Received: 11/28/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial

Patient Treatment Data

Date Received: 01/23/2017 Patient Sequence Number: 1