MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US PINN LNR CON +4 10D 28IDX48OD; PINNACLE HIP SYSTEM : HIP CONSTRAINED ACETABULAR LINERS

Model Number	1218-28-748
Medical Device Problem Code	Device Dislodged or Dislocated (2923)
Health Effect - Clinical Codes	Foreign Body Reaction (1868); Joint Dislocation (2374); No Code Available (3191)
Date of Event	08/13/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.
Event or Problem Description
Hip revision, 2nd one.Patient had high iron level pre op.Liner exchange.Metallosis found in patient.Ring of constraint liner in situ was off the liner.
Additional 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.
Additional Manufacturer Narrative
Product complaint # (b)(4).This report is being submitted pursuant to the provisions of 21 cfr, part 803.This report may be based on information which has not been investigated or verified prior to the required reporting date.This report does not reflect a conclusion by depuy synthes joint reconstruction, or its employees that the report constitutes an admission that the product, depuy synthes joint reconstruction, or its employees caused or contributed to the potential event described in this report.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.

• Brand Name: PINN LNR CON +4 10D 28IDX48OD
• Common Device Name: PINNACLE HIP SYSTEM : HIP CONSTRAINED ACETABULAR LINERS
• Manufacturer (Section D): DEPUY ORTHOPAEDICS INC US; 700 orthopaedic drive; warsaw IN 46581 0988
• MDR Report Key: 10471392
• Report Number: 1818910-2020-19049
• Device Sequence Number: 2407509
• Product Code: KWZ
• UDI-Device Identifier: 10603295011521
• UDI-Public: 10603295011521
• Combination Product (Y/N): N
• Initial Reporter Country: SF
• PMA/510(K) Number: K043058
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2013
• Device Explanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 08/14/2020

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
• Operator of Device: Health Professional
• Device Model Number: 1218-28-748
• Device Catalogue Number: 121828748
• Device Lot Number: EK4DF1000
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 08/14/2020
• Supplement Date Received by Manufacturer: 09/10/2020; 10/23/2020
• Initial Report FDA Received Date: 08/31/2020
• Supplement Report FDA Received Date: 09/22/2020; 10/23/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: APEX HOLE ELIM POSITIVE STOP; ARTICUL/EZE BALL 28 +5 BR; CORAIL2 STD SIZE 10; DLT TS CER HD 12/14 28MM +5.0; DLT TS CER HD 12/14 28MM +5.0; PINN MAR LIP LNR 28IDX48OD; PINNACLE 300 ACET CUP 48MM; APEX HOLE ELIM POSITIVE STOP; ARTICUL/EZE BALL 28 +5 BR; CORAIL2 STD SIZE 10; DLT TS CER HD 12/14 28MM +5.0; PINN MAR LIP LNR 28IDX48OD; PINNACLE 300 ACET CUP 48MM
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 85 YR