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); Fall (1848); Loss of Range of Motion (2032); Discomfort (2330); Unspecified Tissue Injury (4559); Physical Asymmetry (4573); Swelling/ Edema (4577); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Date 08/12/2020

Event Type  Injury  

Manufacturer Narrative

Product complaint #: (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

Litigation papers allege pain, discomfort, swelling, elevated metal ion levels, immobilization, acute localized damage to tissue and/or bone surrounding the acetabulum, and elevated metal ion levels. Update rec¿d (b)(6) 2014 - plaintiff¿s preliminary disclosure form was received, which identified dob information. Part/lot was identified from patient sticker sheet. The complaint and associated mdrs were updated. There was no new information that would change the outcome of the investigation. The complaint was updated on: (b)(6) 2014. Update ad (b)(6) 2021: (b)(4) has been reopened under due to the receipt of medical record. Revision notes stated that scarred bursal layer was removed. The cup was grossly loose and was removed. Upon removal there was a defect in the medial wall. Patient had a preoperative leg length discrepancy and previously sustained a fall with periprosthetic fracture of femur, stem had subsided. Stem and sleeve were added due to elevated metal ion. Doi: (b)(6) 2007 - dor: (b)(6) 2020 (right 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: 12033061
• MDR Text Key: 261704240
• Report Number: 1818910-2021-13082
• Device Sequence Number: 1
• Product Code: KWA
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K040627
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other

Reporter Occupation

• Remedial Action: Recall
• Type of Report: Initial,Followup
• Report Date: 08/23/2013

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/21/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No

Device Operator

• Device Expiration Date: 02/28/2012
• Device Catalogue Number: 999800312
• Device Lot Number: 2345532
• 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: 07/16/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/01/2007
• 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: 06/21/2021 Patient Sequence Number: 1