MAUDE Adverse Event Report: DEPUY INTERNATIONAL LTD - 8010379 ADAPTER SLEEVES 12/14 +5 HIP FEMORAL SLEEVE

Catalog Number 999800315

Device Problems Adverse Event Without Identified Device or Use Problem (2993); Insufficient Information (3190)

Patient Problems Adhesion(s) (1695); Foreign Body Reaction (1868); Muscular Rigidity (1968); Pain (1994); Anxiety (2328); Distress (2329); Discomfort (2330); Osteolysis (2377); Limited Mobility Of The Implanted Joint (2671); Not Applicable (3189); No Code Available (3191)

Event Date 04/20/2009

Event Type  Injury  

Manufacturer Narrative

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

Event Description

Litigation alleges that the patient suffered the following on account of his asr left hip implant: pain; discomfort; stiffness; soreness;clicking; elevated levels of cobalt and chromium. In addition, the patient has been negatively affected in his ability to ambulate causing him to walk with a limp. Litigation further alleges that the patient has been explanted. Update apr 11, 2018: asr litigation records received. In addition to what was previously reported, patient alleges anxiety, inability to perform normal activities, suffering and emotional distress. Added date of revision, account name and associated contact. Added stem and cup due to alleged elevated metal ion levels. Doi: (b)(6) 2009 : dor: (b)(6) 2017 (left hip).

Manufacturer Narrative

(b)(4). Investigation summary : this hip replacement platform was voluntarily recalled from the market and the product codes are now considered inactive. Depuy considers the investigation closed. Should additional information be received, the information will be reviewed and the investigation will be re-opened as necessary. If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.  .

• Brand Name: ADAPTER SLEEVES 12/14 +5
• Type of Device: 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 anthonys road; leeds LS11 8 DT; UK LS11 8 DT
• Manufacturer Contact: kara ditty-bovard ; 700 orthopaedic dr.; warsaw, IN 46582 ; 6107428552
• MDR Report Key: 7490878
• MDR Text Key: 107485953
• Report Number: 1818910-2018-59026
• Device Sequence Number: 1
• Product Code: KWY
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: NI
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,other

Reporter Occupation

• Remedial Action: Recall
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 04/11/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/07/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No

Device Operator

• Device Expiration Date: 01/31/2014
• Device Catalogue Number: 999800315
• Device Lot Number: 2823781
• 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: 06/01/2020
• Was Device Evaluated by Manufacturer?: No Answer Provided
• Date Device Manufactured: 01/21/2009
• 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: 05/07/2018 Patient Sequence Number: 1