MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US DURALOC BANTAM ACET CUP 38 OD; DURALOC IMPLANT : HIP METAL ACETABULAR CUPS

Catalog Number	124538503
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Pain (1994); Osteolysis (2377)
Date of Event	10/15/2023
Type of Reportable Event	Malfunction
Event or Problem Description
Post-op pain.Patient underwent hip replacement surgery in 2014.Approximately 9 years post-op, the patient experienced pain.The patient went to hospital for x-ray examination, and osteolysis was found at acetabular side.The patient require a second surgery, but the specific surgical time is currently unknown.Doi- on (b)(6) 2014, dor- tbd, unknown side.
Additional Manufacturer Narrative
Product complaint (b)(4).Investigation summary post-op pain.Patient underwent hip replacement surgery in 2014.Approximately 9 years post-op, the patient experienced pain.The patient went to hospital for x-ray examination, and osteolysis was found at acetabular side.The patient require a second surgery, but the specific surgical time is currently unknown.The product was not returned to depuy synthes, however an x-ray was provided for review.See attachment "complaint prduct picture of (b)(4)." review of the provided evidence revealed that the femoral head appears to have a non-central position regarding the inner surface of the duraloc bantam acet cup 38 od, most likely caused due to a disassociation between the acetabular cup and 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, 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 [124538503 / 290673] number, and no non-conformances / manufacturing irregularities related to the reported event were identified during manufacturing.The overall complaint was confirmed as the observed condition of the duraloc bantam acet cup 38 od would contribute to the complained event.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 [124538503 / 290673] number, and no non-conformances / manufacturing irregularities related to the reported event were identified during manufacturing.This report is being submitted pursuant to the provisions of 21 cfr, part 803 (and/or part 4, as applicable).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, or its employees that the report constitutes an admission that the product, 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 report, a follow-up report will be filed as appropriate.

• Brand Name: DURALOC BANTAM ACET CUP 38 OD
• Common Device Name: DURALOC IMPLANT : 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 ; 3035526892
• MDR Report Key: 18552424
• Report Number: 1818910-2024-01514
• Device Sequence Number: 15055918
• Product Code: LPH
• UDI-Device Identifier: 10603295019404
• UDI-Public: 10603295019404
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K961186
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2014
• 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
• Report Date (Section B): 01/22/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 10/03/2022
• Device Catalogue Number: 124538503
• Device Lot Number: 290673
• 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: 01/19/2024
• Initial Report FDA Received Date: 01/22/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 10/03/2012
• 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: DURALOC BANTAM ACET CUP 38 OD; S-ROM*HEAD FEMORAL COCR 22+0; S-ROM*SLEEVE PRX ZTT, 12B-SML; S-ROM*STM STD,30 NK,12X07X115
• Patient Sex: Unknown