MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US ALTRX NEUT 28IDX52OD; PINNACLE HIP SYSTEM : HIP POLY ACETABULAR LINERS

Model Number	1221-28-052
Medical Device Problem Codes	Device Dislodged or Dislocated (2923); Naturally Worn (2988); Noise, Audible (3273)
Health Effect - Clinical Codes	Pain (1994); No Code Available (3191)
Date of Event	06/09/2020
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 patient presented with a painful hip after hearing a popping sound.Surgeon believed the poly liner may have disassociated and elected to revise the hip.The poly liner was disassociated and many of the locking tabs were worn away.Surgeon diligently inspected the locking mechanism for damaged and elected to place a new poly in the existing cup and exchange the 28 bceramic head for a ts ceramic 36 head.Doi: (b)(6) 2012, dor: (b)(6) 2020, affected side: right hip.
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.H10 additional narrative: re-captured device codes.Removed code for noise.

• Brand Name: ALTRX NEUT 28IDX52OD
• 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: 10184462
• Report Number: 1818910-2020-14278
• Device Sequence Number: 3298393
• Product Code: LPH
• UDI-Device Identifier: 10603295015963
• UDI-Public: 10603295015963
• Combination Product (Y/N): N
• Initial Reporter State: IN
• Initial Reporter Country: US
• PMA/510(K) Number: K072963
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2012
• Device Explanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 06/09/2020

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: 1221-28-052
• Device Catalogue Number: 122128052
• Device Lot Number: 221295
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 06/09/2020
• Supplement Date Received by Manufacturer: 08/05/2020
• Initial Report FDA Received Date: 06/23/2020
• Supplement Report FDA Received Date: 08/05/2020
• 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: DELTA CER HEAD 12/14 28MM +5; UNKNOWN HIP ACETABULAR CUP; DELTA CER HEAD 12/14 28MM +5; UNKNOWN HIP ACETABULAR CUP
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 48 YR