MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US PINN MAR NEUT 32IDX58OD; HIP ACETABULAR LINERS

Catalog Number	121932058
Medical Device Problem Codes	Device Dislodged or Dislocated (2923); Naturally Worn (2988)
Health Effect - Clinical Code	Pain (1994)
Date of Event	06/15/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
Surgeon is reporting an inlay luxation left side.Inlay luxated from cup in caudal direction.Hip-head was trapped cranially between metal and pe inlay.Revision of inlay and head.Doi: about 13 yrs ago in another hospital.Dor: (b)(6) 2023.Left hip.
Additional Manufacturer Narrative
Product complaint # (b)(4).D4-the device catalog number is unknown; therefore, udi is unavailable.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.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).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: d10 if information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.Corrected: h6 (removed pec for implant noise for the head and cup since there was no allegation in the event that there was an implant sound).
Event or Problem Description
Additional information received: a.Was there a surgical delay? if yes, what is the duration of the delay? -> no b.Was there any adverse consequence to the patient relevant to this event? if yes, please kindly provide details.-> revision with head and inlay change.C.Was there any allegation against the cup? -> no.
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.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 surgeon is reporting an inlay luxation left side.Inlay luxated from cup in caudal direction.Hip-head was trapped cranially between metal and pe inlay.Revision of inlay and head.Doi: about 13 yrs ago in another hospital.The product was returned to depuy synthes for evaluation.The depuy synthes team conducted a visual inspection of the returned device.Visual examination of the device found two anti-rotation device (ard) tabs sheared off from the rim of the pinn mar neut 32idx58od, fragments were not returned for evaluation.Deformation was also found on the edge of the liner as well as wear of it.It is not unreasonable to find signs of wear after explantation considering the device has been implanted for about 13 years as stated on the event description.Based on the observations, it is reasonable to conclude that a disassociation event occurred between the liner and the cup.With the information provided is not possible to determine a potential cause at this moment.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.A manufacturing record evaluation was performed for the finished device [121932058 / ex6hd1] number, and no non-conformances / manufacturing irregularities were identified during manufacturing.The overall complaint was confirmed as the observed condition of the pinn mar neut 32idx58od 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: 1) quantity manufactured: 20 2) date of manufacture: jun 16th 2010 3) any anomalies or deviations identified in dhr: none 4) expiry date: 2015-06 5) ifu reference: (b)(4).Device history review: a manufacturing record evaluation was performed for the finished device [121932058 / ex6hd1] number, and no non-conformances / manufacturing irregularities were identified during manufacturing.

• Brand Name: PINN MAR NEUT 32IDX58OD
• Common Device Name: HIP 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: 17216037
• Report Number: 1818910-2023-13219
• Device Sequence Number: 12308478
• Product Code: LPH
• UDI-Device Identifier: 10603295013938
• UDI-Public: 10603295013938
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K001534
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• 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,Followup,Followup,Followup
• Report Date (Section B): 06/28/2023

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 Catalogue Number: 121932058
• Device Lot Number: EX6HD1
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/16/2023
• Supplement Date Received by Manufacturer: 07/27/2023; 09/04/2023; 09/05/2023; 09/13/2023
• Initial Report FDA Received Date: 06/28/2023
• Supplement Report FDA Received Date: 08/01/2023; 09/05/2023; 09/06/2023; 09/13/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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: PINN MAR NEUT 32IDX58OD; UNKNOWN HIP ACETABULAR CUP; UNKNOWN HIP ACETABULAR CUP; UNKNOWN HIP ACETABULAR LINERS; UNKNOWN HIP FEMORAL HEAD; UNKNOWN HIP FEMORAL HEAD
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown