MAUDE Adverse Event Report: DEPUY INTERNATIONAL LTD - 8010379 EA DELTA CER INSERT 36IDX52OD; PINNACLE HIP SYSTEM : HIP CERAMIC ACETABULAR LINERS

Catalog Number 121881752

Device Problem Device Dislodged or Dislocated (2923)

Patient Problems Joint Dislocation (2374); No Code Available (3191)

Event Date 02/26/2012

Event Type  Injury  

Manufacturer Narrative

Product complaint # (b)(4).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

Asr re-revision.Information received from (b)(6).Asr revised (b)(6) 2012.Revised to pinnacle ceramic.Pinnacle ceramic products revised due to dislocation (not arising from traumatic event).Hip(s) to be revised: left doi: (b)(6) 2012 - dor: (b)(6) 2012 (left hip).

Manufacturer Narrative

Product complaint # (b)(4).Investigation summary: no device associated with this report was received for examination.A worldwide complaint database search found no other reported incident(s) against the provided product/lot combination(s) since release for distribution.Based on previous investigations this complication of joint replacement is unlikely to have been the result of a device failing to meet required specifications.The information received will be retained for potential series investigations if triggered by trend analysis, post market surveillance, or other events within the quality system.Corrective action was not indicated.

• Brand Name: EA DELTA CER INSERT 36IDX52OD
• Type of Device: PINNACLE HIP SYSTEM : HIP CERAMIC ACETABULAR LINERS
• Manufacturer (Section D): DEPUY INTERNATIONAL LTD - 8010379; st. anthony's road; leeds LS11 8DT; UK LS11 8DT
• MDR Report Key: 10514755
• MDR Text Key: 206338429
• Report Number: 1818910-2020-19767
• Device Sequence Number: 1
• Product Code: MRA
• Combination Product (y/n): N
• PMA/PMN Number: P070026
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,foreign,other
• Type of Report: Initial,Followup
• Report Date: 08/18/2020

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?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 121881752
• Device Lot Number: 3359224
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 08/18/2020
• Initial Date FDA Received: 09/10/2020
• Supplement Dates Manufacturer Received: 10/05/2020
• Supplement Dates FDA Received: 10/07/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: DLT TS CER HD 12/14 36MM +12; PINNACLE SECTOR II CUP 62MM; DLT TS CER HD 12/14 36MM +12; PINNACLE SECTOR II CUP 62MM
• Patient Outcome(s): Required Intervention