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

Catalog Number 999800315

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

Patient Problems Foreign Body Reaction (1868); Pain (1994); Tissue Damage (2104); Test Result (2695); No Code Available (3191)

Event Date 04/08/2019

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

After review of medical records, the patient was revised to address pain and elevated chromium and cobalt levels.Granulomatous tissue, damage to abductors and metallosis were noted intraoperatively.Doi: (b)(6) 2008; dor: (b)(6) 2019; (right hip).

Manufacturer Narrative

Product complaint # (b)(4).Investigation summary
=
> this hip replacement platform was voluntarily recalled from the market and the product codes are now considered inactive.Further investigation of this individual incident will not be undertaken.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: 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 anthonys road; leeds LS11 8 DT; UK LS11 8 DT
• Manufacturer Contact: kara ditty-bovard ; 1210 ward avenue; west chester, PA 19380-0988 ; 6107428552
• MDR Report Key: 9415964
• MDR Text Key: 169236069
• Report Number: 1818910-2019-120632
• Device Sequence Number: 1
• Product Code: KXA
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other
• Reporter Occupation: Other
• Remedial Action: Recall
• Type of Report: Initial,Followup
• Report Date: 11/11/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/05/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 02/28/2013
• Device Catalogue Number: 999800315
• Device Lot Number: 2555667
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 12/19/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/21/2008
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Removal/Correction Number: Z-1749/1816-2011
• Patient Sequence Number: 1
• Treatment: APEX HOLE ELIM POSITIVE STOP (124603000/CP6J71000); PINNACLE 300 ACET CUP 54MM (121703054/B5WCB1000); PINNACLE MTL INS NEUT36IDX54OD (121887354/2558456)
• Patient Outcome(s): Required Intervention
• Patient Age: 74 YR