MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US PINNACLE MULTIHOLE II CUP 50MM; PINNACLE HIP SYSTEM : HIP METAL ACETABULAR CUPS

Catalog Number	121720050
Medical Device Problem Code	Naturally Worn (2988)
Health Effect - Clinical Code	Inflammation (1932)
Date of Event	01/01/2023
Type of Reportable Event	Serious Injury
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.
Event or Problem Description
It was reported that the patient return for an x-ray as part of follow up and it was identified that the implant was fractured.A revision surgery was arranged and performed on (b)(6) 2023.Upon removal, the implant was found to be fractured and 2 other devices were found to be scratched.Pinnacle porocoat multihole coating scratched off surface.Altrx liner cracked.Ceramic head surface scratched.Doi: unknown.Doe: (b)(6) 2023.Affected side: unknown.
Additional Manufacturer Narrative
Product complaint#: (b)(4).Investigation summary: the patient return for an x-ray as part of follow up and it was identified that the implant was fractured.A revision surgery was arranged and performed on (b)(6) 2023.Upon removal, the implant was found to be fractured and 2 other devices were found to be scratched.Pinnacle porocoat multihole coating scratched off surface.Altrx liner cracked ceramic head surface scratched.The product was not returned to depuy synthes, however photos were provided for review.Review of the photographic evidence found signs of metal transfer on the outer surface of the ceramic head, consistent with material transfer from the inner surface of the cup as a result of a disassociation of the liner from the acetabular cup.It is expected that not all coating might still be attached to the cup once explanted.The overall complaint was confirmed as the pinnacle multihole ii cup 50mm 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 device lot number is unknown, therefore a device history review could not be performed. if the lot/serial number becomes available, the record will be re-assessed.
Additional Manufacturer Narrative
Product complaint #(b)(4).Investigation summary = the patient return for an x-ray as part of follow up and it was identified that the implant was fractured.A revision surgery was arranged and performed on (b)(6) 2023.Upon removal, the implant was found to be fractured and 2 other devices were found to be scratched.Pinnacle porocoat multihole coating scratched off surface.Altrx liner cracked ceramic head surface scratched.The product was not returned to depuy synthes, however photos were provided for review.Review of the photographic evidence found signs of what appears to be wear on the outer porocoating of the cup, it is expected that not all coating might still be attached to the cup once explanted.Based on the observation of the ceramic head and liner on the provided photos, it can be concluded that a disassociation event occurred between the acetabular cup and poly liner.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 [121720050 / jh3633] number, and no non-conformances / manufacturing irregularities were identified during manufacturing.The overall complaint was confirmed as the pinnacle multihole ii cup 50mm 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 = a manufacturing record evaluation was performed for the finished device [121720050 / jh3633] number, and no non-conformances / manufacturing irregularities were identified during manufacturing.Device history review = a manufacturing record evaluation was performed for the finished device [121720050 / jh3633] number, and no non-conformances / manufacturing irregularities were identified during manufacturing.

• Brand Name: PINNACLE MULTIHOLE II CUP 50MM
• Common Device Name: PINNACLE HIP SYSTEM : HIP METAL ACETABULAR CUPS
• 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: 17397416
• Report Number: 1818910-2023-15249
• Device Sequence Number: 14941207
• Product Code: LPH
• UDI-Device Identifier: 10603295009610
• UDI-Public: 10603295009610
• Combination Product (Y/N): N
• Initial Reporter Country: SN
• PMA/510(K) Number: P070026
• 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
• Report Date (Section B): 07/26/2023

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: 121720050
• Device Lot Number: JH3633
• 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: 07/16/2023
• Supplement Date Received by Manufacturer: 09/29/2023; 10/06/2023
• Initial Report FDA Received Date: 07/26/2023
• Supplement Report FDA Received Date: 10/01/2023; 10/10/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 07/06/2021
• 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: PINNACLE MULTIHOLE II CUP 50MM.
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown