MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US PINN MAR +4 NEUT 32IDX54OD; PINNACLE HIP SYSTEM : HIP POLY ACETABULAR LINERS

Model Number	1219-32-454
Medical Device Problem Code	Device Dislodged or Dislocated (2923)
Health Effect - Clinical Codes	Joint Dislocation (2374); No Code Available (3191)
Date of Event	09/03/2020
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
It was reported that the patient had her hip replaced in 2007 by dr.(b)(6).The patient did well until recently when she had dislocated her hip multiple times and had to have it reduced in the er.The exact date of the primary surgery is unknown, the exact dates of dislocations are unknown.The surgeon explanted a 54 + 4 neutral marathon liner and a 32mm + 3 metal srom hip ball to treat recurrent dislocations and joint instability.A new 36mm + 4 10 degree 54mm liner and a 36mm + 9 ceramic srom hip ball were implanted.Doi: 2007.Dor: (b)(6) 2020; affected side: right hip.
Additional Manufacturer Narrative
Product complaint # (b)(4).H10 additional narrative: added: d4 lot number.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.

• Brand Name: PINN MAR +4 NEUT 32IDX54OD
• Common Device Name: PINNACLE HIP SYSTEM : HIP POLY ACETABULAR LINERS
• Manufacturer (Section D): DEPUY ORTHOPAEDICS INC US; 700 orthopaedic drive; warsaw IN 46581 0988
• MDR Report Key: 10547403
• Report Number: 1818910-2020-20348
• Device Sequence Number: 11649192
• Product Code: LPH
• UDI-Device Identifier: 10603295014348
• UDI-Public: 10603295014348
• Combination Product (Y/N): N
• Initial Reporter State: MI
• Initial Reporter Country: US
• PMA/510(K) Number: K001534
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Explanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 09/03/2020

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: 1219-32-454
• Device Catalogue Number: 121932454
• Device Lot Number: XD2DJ1
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 09/03/2020
• Supplement Date Received by Manufacturer: 09/03/2020; 10/27/2020
• Initial Report FDA Received Date: 09/17/2020
• Supplement Report FDA Received Date: 09/17/2020; 10/27/2020
• 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: PINN MAR +4 NEUT 32IDX54OD; PINNACLE CUP; S-ROM HEAD FEMORAL COCR 32+3; SROM SLEEVE; SROM STEM; PINN MAR +4 NEUT 32IDX54OD; PINNACLE CUP; S-ROM HEAD FEMORAL COCR 32+3; SROM SLEEVE; SROM STEM
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Weight: 60