MAUDE Adverse Event Report: DEPUY INTERNATIONAL LTD. 8010379 ADAPTER SLEEVE 11/13 +0; ASR HIP SYSTEM : HIP FEMORAL SLEEVE

Catalog Number 999890340

Device Problem Corroded (1131)

Patient Problems Host-Tissue Reaction (1297); Pain (1994); Injury (2348); Osteolysis (2377); Test Result (2695); No Code Available (3191)

Event Date 06/21/2018

Event Type  Injury  

Manufacturer Narrative

Product complaint # (b)(4).If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.Device was used for treatment, not diagnosis.Initial reporter occupation: non-healthcare professional "attorney".(b)(4).

Event Description

Asr litigation alleges injury, pain, popping and grinding sensation, increased metal levels, adverse reaction to the metal, and significant taper corrosion at the trunnion.Doi: (b)(6) 2006 - (b)(6) 2018 (left hip).

Manufacturer Narrative

Product complaint # (b)(4).

Event Description

After review of medical record, the patient was revised to address pain, elevated metal levels and osteolysis.Revision notes reported that acetabular component had some slight posterior defect.There was a copious fibrous tissue within the capsule which was excised.There was significant taper corrosion at the level of the trunnion.

Manufacturer Narrative

Depuy synthes is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on information which depuy synthes has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy synthes or its employees that the report constitutes an admission that the device, depuy synthes, or its employees caused or contributed to the potential event described in this report.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.

Manufacturer Narrative

Product complaint #: (b)(4).Depuy synthes is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on information which depuy synthes has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy synthes or its employees that the report constitutes an admission that the device, depuy synthes, or its employees caused or contributed to the potential event described in this report.

• Brand Name: ADAPTER SLEEVE 11/13 +0
• Type of Device: ASR HIP SYSTEM : HIP FEMORAL SLEEVE
• Manufacturer (Section D): DEPUY INTERNATIONAL LTD. 8010379; st. anthony's rd; leeds LS11 8 DT; UK LS11 8 DT
• MDR Report Key: 8315234
• MDR Text Key: 135367366
• Report Number: 1818910-2019-83536
• Device Sequence Number: 1
• Product Code: KWL
• Combination Product (y/n): N
• PMA/PMN Number: K965156
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other
• Remedial Action: Recall
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 01/15/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 02/28/2011
• Device Catalogue Number: 999890340
• Device Lot Number: 2089754
• Initial Date Manufacturer Received: 01/15/2019
• Initial Date FDA Received: 02/07/2019
• Supplement Dates Manufacturer Received: 02/04/2019; 02/13/2019; 04/17/2019
• Supplement Dates FDA Received: 02/12/2019; 02/14/2019; 04/26/2019
• Removal/Correction Number: Z-1749/1816-2011
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 77 YR