MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US ALTRX +4 10D 28IDX46OD; PINNACLE HIP SYSTEM : HIP POLY ACETABULAR LINERS

Model Number	1221-28-146
Medical Device Problem Code	Device Dislodged or Dislocated (2923)
Health Effect - Clinical Codes	Joint Dislocation (2374); Joint Laxity (4526)
Date of Event	05/23/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
Hip instability with recurrent dislocation.
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).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: b1 (is product problem), d4 (lot) and h4.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.Unknown hip acetabular cup was updated to pinnacle bantam acet cup 46mm.
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 manufacturing record evaluation (mre), was not possible because the required lot code was not provided.
Additional Manufacturer Narrative
Product complaint #(b)(4).Investigation summary: hip instability with recurrent dislocation.The product was not returned to depuy synthes, however photos were provided for review.See attachment (depuy23-53 picture 1 and depuy23-53 picture 2).Visual analysis of the photo provided for the altrx +4 10d 28idx46od was found the liner with a hole in most likely caused during removal of the device.Furthermore, the head shows abrasion (black smears) that are consistent with the head coming into contact with titanium metal.This could have only occurred after dislocation of the head from the liner at which point the ceramic head may have rubbed against the edge of the titanium cup, where abrasions were also noted.Therefore, dislocation between the head and liner is confirmed.The mode of failure of the device is multi-factorial and consideration must be given to all other potential influences such as surgical process, patient variables (e.G.Activity level and use), anatomical considerations and patient changes over time.Any conclusions from the investigational input provided have to be placed into context with all other relevant factors.The overall complaint was confirmed as the observed condition of the altrx +4 10d 28idx46od 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 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: quantity manufactured: (b)(4); date of manufacture: 8/16/2017; any anomalies or deviations identified in dhr: none; expiry date: 31/07/2022; ifu reference: ifu-090200701.Device history review: quantity manufactured: (b)(4); date of manufacture: 8/16/2017; any anomalies or deviations identified in dhr: none; expiry date: 31/07/2022; ifu reference: ifu-090200701.

• Brand Name: ALTRX +4 10D 28IDX46OD
• 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 orthpaedic dr.; warsaw, IN 46581 ; 3035526892
• MDR Report Key: 17152642
• Report Number: 1818910-2023-12429
• Device Sequence Number: 12255299
• Product Code: LPH
• UDI-Device Identifier: 10603295015994
• UDI-Public: 10603295015994
• Combination Product (Y/N): N
• Initial Reporter Country: IT
• PMA/510(K) Number: K072963
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Device Explanted Year: 2023
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date (Section B): 06/19/2023

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 Model Number: 1221-28-146
• Device Catalogue Number: 122128146
• Device Lot Number: HD9995
• 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: 06/06/2023
• Supplement Date Received by Manufacturer: 06/29/2023; 06/28/2023; 08/31/2023; 10/03/2023
• Initial Report FDA Received Date: 06/19/2023
• Supplement Report FDA Received Date: 06/30/2023; 07/07/2023; 09/08/2023; 10/04/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 08/11/2017
• 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: DELTA CER HEAD 12/14 28MM +1.5; PINNACLE BANTAM ACET CUP 46MM; UNKNOWN HIP ACETABULAR CUP; UNKNOWN HIP FEMORAL HEAD
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 79 YR
• Patient Sex: Unknown