MAUDE Adverse Event Report: DEPUY INTERNATIONAL LTD - 8010379 ADAPTER SLEEVES 12/14 +2 ASR HIP SYSTEM : HIP FEMORAL SLEEVE

Catalog Number 999800312

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

Patient Problems Adhesion(s) (1695); Cyst(s) (1800); Foreign Body Reaction (1868); Pain (1994); Loss of Range of Motion (2032); Discomfort (2330); Physical Asymmetry (4573); Swelling/ Edema (4577); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Date 05/05/2020

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

Patient had elevated metal ion. Revision notes stated that scar excision was performed including removal of abnormal appearing tissue. A minimal sized fluid collection was evacuated. There was some evidence of corrosion at the trunnion. There was near impingement with extension and external rotation of the hip. The cup was too anteverted and vertical. Leg lengths looked short. Cup, head. And sleeve were removed. Operative findings stated that a local soft tissue response and fluid collection in line with an adverse metal on metal reaction was found. There are some contained boney defects on the acetabular side that was bone grafted. There was also some posterior superior bone loss and medial. The local soft tissues were stained in a way that is characteristic for a metal on metal failure. Added patient's dob, medical history, and laboratory data. Corrected patient's initials. Added head, sleeve, and stem due to elevated metal ion reported. Added date of implantation. Doi: (b)(6) 2006, dor: (b)(6) 2020. (left hip).

• Brand Name: ADAPTER SLEEVES 12/14 +2
• Type of Device: ASR HIP SYSTEM : HIP FEMORAL SLEEVE
• Manufacturer (Section D): DEPUY INTERNATIONAL LTD - 8010379; st. anthony's road; leeds LS11 8DT; UK LS11 8DT
• 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: 12189689
• MDR Text Key: 262243648
• Report Number: 1818910-2021-15453
• Device Sequence Number: 1
• Product Code: KWA
• Combination Product (y/n): N
• PMA/PMN Number: K040627
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,other
• Remedial Action: Recall
• Type of Report: Initial,Followup,Followup
• Report Date: 07/05/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/19/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No

Device Operator

• Device Catalogue Number: 999800312
• Device Lot Number: 2160169
• Was Device Available for Evaluation?: No

Was the Report Sent to FDA?

• Event Location: No Information
• Date Manufacturer Received: 09/28/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/02/2006
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Removal/Correction Number: Z-1749/1816-2011

Patient Treatment Data

Date Received: 07/19/2021 Patient Sequence Number: 1

Treatment

ADAPTER SLEEVES 12/14 +2; ASR ACETABULAR CUPS 50; ASR UNI FEMORAL IMPL SIZE 45; SUMMIT POR TAPER SZ3 STD OFF