MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US PINNACLE MTL INS NEUT36IDX52OD PINNACLE HIP SYSTEM : HIP METAL ACETABULAR LINERS

Model Number 1218-87-352

Device Problem Naturally Worn (2988)

Patient Problems Inflammation (1932); Pain (1994); Swelling/ Edema (4577); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Date 08/31/2020

Event Type  Injury  

Manufacturer Narrative

(b)(4). Initial reporter occupation: lawyer (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 as failed total hip. Patient was revised to address failure of right total hip arthroplasty and trochanteric bursitis of right hip. Revision notes reported that there was metalic stained synovium and synovial fluid and laboratory values revealed an elevated cobalt chromium serum level. The patient was instructed to continue to ice and elevate operative leg for pain and swelling control. The patient is status post right total hip arthroplasty in the past with metal on metal bearing. Doi: unknown. Dor: (b)(6) 2020. Affected side: right hip.

• Brand Name: PINNACLE MTL INS NEUT36IDX52OD
• 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 anthonys road; leeds LS11 8 DT; UK LS11 8 DT
• Manufacturer Contact: kara ditty-bovard ; 700 orthopaedic dr.; warsaw, IN 46581-0988 ; 6107428552
• MDR Report Key: 11049639
• MDR Text Key: 223051787
• Report Number: 1818910-2020-27386
• Device Sequence Number: 1
• Product Code: KWA
• Combination Product (Y/N): N
• Reporter Country Code: US
• PMA/PMN Number: K003523
• 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: 08/31/2020

1 Device Was Involved in the Event

1 Patient Was Involved in the Event

• Date FDA Received: 12/21/2020
• Is This An Adverse Event Report?: Yes
• Is This A Product Problem Report?: Yes
• Device Operator: HEALTH PROFESSIONAL
• Device EXPIRATION Date: 05/31/2013
• Device MODEL Number: 1218-87-352
• Device Catalogue Number: 121887352
• Device LOT Number: 2625255
• Was Device Available For Evaluation?: No Answer Provided
• Is The Reporter A Health Professional?: Yes

Was the Report Sent to FDA?

• Event Location: No Information
• Date Manufacturer Received: 01/05/2021
• Was Device Evaluated By Manufacturer?: Device Not Returned To Manufacturer
• Date Device Manufactured: 05/22/2008
• Is The Device Single Use?: No

Is this a Reprocessed and Reused Single-Use Device?

• Type of Device Usage: Initial
• Removal/Correction Number: N/A

Patient TREATMENT DATA

Date Received: 12/21/2020 Patient Sequence Number: 1