MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US PINNACLE MTL INS NEUT36IDX62OD PINNACLE HIP SYSTEM : HIP METAL ACETABULAR LINERS

Model Number 1218-87-362

Device Problem Naturally Worn (2988)

Patient Problems Pain (1994); Discomfort (2330); Test Result (2695); No Code Available (3191)

Event Date 10/09/2020

Event Type  Injury  

Manufacturer Narrative

(b)(4). 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 this patient had his right hip replaced in 2004 at one of the (b)(6) medical center facility by dr. (b)(6). The patient was seen by dr. (b)(6). For right hip pain and discomfort some time ago and was being monitored by dr. (b)(6). For elevated ions due to a metal on metal articulation. This patient¿s hip was aspirated numerous times and dr. (b)(6). Stated the fluid was cloudy and dark color. Dr. (b)(6) assumed it was most likely metal wear particulate in the patients fluid. The patient and dr. (b)(6). Made the decision to revise the patients hip construct and explant the metal liner and metal head and implant a poly liner and a titanium sleeve ceramic femoral hip ball. The summit stem and 62mm pinnacle cup were left in situ. I do not have lot # information to share with you on the stem and cup that were originally implanted. Original implant date unknown. Doi: 2014. Dor: (b)(6) 2020 affected side: right hip.

• Brand Name: PINNACLE MTL INS NEUT36IDX62OD
• Type of Device: PINNACLE HIP SYSTEM : HIP METAL ACETABULAR LINERS
• Manufacturer (Section D): DEPUY ORTHOPAEDICS INC US; 700 orthopaedic drive; warsaw IN 46581 0988
• Manufacturer (Section G): DEPUY INT'L LTD. 8010379; st. anthony's rd; leeds LS11 8 DT; UK LS11 8 DT
• Manufacturer Contact: kara ditty-bovard ; 700 orthopaedic dr.; warsaw, IN 46581-0988 ; 6107428552
• MDR Report Key: 10726780
• MDR Text Key: 212734452
• Report Number: 1818910-2020-23202
• Device Sequence Number: 1
• Product Code: KWA
• Combination Product (Y/N): N
• Reporter Country Code: US
• PMA/PMN Number: K062426
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: COMPANY REPRESENTATIVE,HEALTH
• Reporter Occupation: OTHER HEALTH CARE PROFESSIONAL
• Type of Report: Initial,Followup
• Report Date: 10/09/2020

1 Device Was Involved in the Event

1 Patient Was Involved in the Event

• Date FDA Received: 10/23/2020
• Is This An Adverse Event Report?: Yes
• Is This A Product Problem Report?: Yes
• Device Operator: HEALTH PROFESSIONAL
• Device MODEL Number: 1218-87-362
• Device Catalogue Number: 121887362
• Device LOT Number: 1098343
• Was Device Available For Evaluation?: No
• Is The Reporter A Health Professional?: Yes

Was the Report Sent to FDA?

• Event Location: No Information
• Date Manufacturer Received: 11/30/2020
• Was Device Evaluated By Manufacturer?: Device Not Returned To Manufacturer
• Date Device Manufactured: 04/25/2003
• 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: 10/23/2020 Patient Sequence Number: 1

Treatment

62MM PINNACLE CUP; ARTICULEZE M HEAD 36MM +5; PINNACLE MTL INS NEUT36IDX62OD; SUMMIT STEM