MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US PINN SECTOR HA ACET CUP 50MM; PINNACLE HIP SYSTEM : HIP METAL ACETABULAR CUPS

Model Number	1217-12-050
Medical Device Problem Code	Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	No Code Available (3191)
Date of Event	09/17/2020
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
Surgeon said that he had booked a patient for revision of a dissociated pinnacle liner for surgery today (b)(6).Revision on dissociated liner was completed as planned and surgeon implanted a 32mm id/50mm od altrx poly neutral liner and 32mm +9 biolox delta ts ceramic femoral head (revision).Explanted head and liner not available for return.Patient underwent primary surgery on (b)(6) 2018.Surgeon did not suggest why the liner had failed/dissociated.No further information available.
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.H10 additional narrative: added: b5.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.
Additional Manufacturer Narrative
Product complaint # (b)(4).Investigation summary no device associated with this report was received for examination.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.Depuy considers the investigation closed.Should additional information be received, the information will be reviewed, and the investigation will be re-opened as necessary.Device history lot a search of the depuy nonconformance (nc) quality system found no nc¿s associated with this product/lot combination.
Event or Problem Description
Additional information received states that the affected side was the left hip.

• Brand Name: PINN SECTOR HA ACET CUP 50MM
• Common Device Name: PINNACLE HIP SYSTEM : HIP METAL ACETABULAR CUPS
• Manufacturer (Section D): DEPUY ORTHOPAEDICS INC US; 700 orthopaedic drive; warsaw IN 46581 0988
• MDR Report Key: 10607370
• Report Number: 1818910-2020-21233
• Device Sequence Number: 2803329
• Product Code: LPH
• UDI-Device Identifier: 10603295009153
• UDI-Public: 10603295009153
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K031495
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Serviced by Third Party (Y/N): Unknown
• 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): 09/17/2020

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: 1217-12-050
• Device Catalogue Number: 121712050
• Device Lot Number: HM3480
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 09/17/2020
• Supplement Date Received by Manufacturer: 09/30/2020; 12/07/2020
• Initial Report FDA Received Date: 09/30/2020
• Supplement Report FDA Received Date: 10/02/2020; 12/08/2020
• 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: CORAIL AMT COLLAR SIZE 11.; DELTA CER HEAD 12/14 32MM +1.; PINN MAR +4 10D 32IDX50OD.; CORAIL AMT COLLAR SIZE 11; DELTA CER HEAD 12/14 32MM +1; PINN MAR +4 10D 32IDX50OD
• Outcome Attributed to Adverse Event: Required Intervention