MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US ALTRX +4 10D 36IDX56OD; PINNACLE HIP SYSTEM : HIP POLY ACETABULAR LINERS

Model Number	1221-36-156
Medical Device Problem Codes	Fracture (1260); Device Dislodged or Dislocated (2923); Material Deformation (2976)
Health Effect - Clinical Codes	Joint Dislocation (2374); Joint Laxity (4526)
Date of Event	06/22/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the patient underwent primary right corail/pinnacle tkr.Patient subsequently has experienced dislocation of joint.Surgeon suspected the cup was in slightly more anteversion than intended.Patient has a +4/10 degree liner in-situ, which in its current orientation was impinging on the neck of the femoral stem, leading to dislocation.Procedure revision of acetabular liner and head change.Surgeon removed existing liner, replaced it with another +4/10 degree liner with the orientation changed.Upon removing the existing liner the surgeon noted an obvious 'dent' in the liner where the neck had been impacting it.Doi: (b)(6)2022.Doe: (b)(6) 2023.Affected side: unknown.
Additional Manufacturer Narrative
Product complaint # (b)(4).Depuy synthes is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on information which depuy synthes has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy synthes or its employees that the report constitutes an admission that the device, depuy synthes, 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 medwatch, a follow-up medwatch will be filed as appropriate.
Additional Manufacturer Narrative
Product complaint # (b)(4).Investigation summary according to the information received, ¿patient underwent primary right corail/pinnacle tkr [month year] patient has subsequently has experienced dislocation of joint.Surgeon suspected the cup was in slightly more anteversion than intended.Patient has a +4/10 degree liner in-situ, which in its current orientation was impinging on the neck of the femoral stem, leading to dislocation.Procedure revision of acetabular liner and head change.Surgeon removed existing liner, replaced it with another +4/10 degree liner with the orientation changed.Upon removing the existing liner the surgeon noted an obvious 'dent' in the liner where the neck had been impacting it (see attachment with photos of explanted liner)¿.The product was not returned to depuy synthes, however photos were provided for review.See attachment "moroney rev st a ipswich.Pdf".Review of the photographic evidence found several scratches around the upper surface of the device and a fracture on the edge, most likely caused during the extraction process.However, no signs of deformation and/or dislocation between the femoral head and liner were observed on the provided evidence.The overall complaint was confirmed as the observed condition of the altrx +4 10d 36idx56od would contribute to the complained device issue.Based on the investigation findings, it has been determined that no corrective and/or preventative action is proposed.There is no indication that a design or manufacturing issue has caused the reported complaint condition.As part of depuy synthes quality process, all devices are manufactured, inspected, and released to approved specifications.Additional monitoring for any potential safety signals will be conducted through complaint trending and other post-market safety surveillance activities.Device history lot the product investigation found no evidence suspecting an error in the manufacturing or material that would be a contributing factor in the reported allegation(s).A manufacturing records evaluation (mre) was not performed.

• Brand Name: ALTRX +4 10D 36IDX56OD
• Common Device Name: PINNACLE HIP SYSTEM : HIP POLY ACETABULAR LINERS
• Manufacturer (Section D): DEPUY ORTHOPAEDICS INC US; 700 orthopaedic drive; warsaw IN 46581 0988
• Manufacturer (Section G): DEPUY ORTHOPAEDICS, INC. 1818910; 700 orthopaedic dr.; warsaw IN 46581 0988
• Manufacturer Contact: kate karberg ; 700 orthopaedic dr.; warsaw, IN 46581-0988 ; 3035526892
• MDR Report Key: 17297304
• Report Number: 1818910-2023-13869
• Device Sequence Number: 7009069
• Product Code: LPH
• UDI-Device Identifier: 10603295016427
• UDI-Public: 10603295016427
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K072963
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• Device Explanted Year: 2023
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 07/11/2023

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 Expiration Date: 02/28/2026
• Device Model Number: 1221-36-156
• Device Catalogue Number: 122136156
• Device Lot Number: JC0494
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/22/2023
• Supplement Date Received by Manufacturer: 09/19/2023
• Initial Report FDA Received Date: 07/11/2023
• Supplement Report FDA Received Date: 09/19/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 03/03/2021
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: APEX HOLE ELIM POSITIVE STOP; CORAIL AMT COLLAR SIZE 12; DELTA CER HEAD 12/14 36MM +5; PINN CAN BONE SCREW 6.5MMX20MM; PINN SECTOR HA ACET CUP 56MM
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 45 YR
• Patient Sex: Female