MAUDE Adverse Event Report: DEPUY IRELAND - 3015516266 BI MENTUM ALTRX LNR 41 22; HIP IMPLANT - ACETABULAR LINER

Catalog Number	122122041
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Unspecified Infection (1930)
Date of Event	04/28/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Product complaint # (b)(4) 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.
Event or Problem Description
It was reported that patient became infected.Dr washed it out and replaced the liners and head.It was unknown, if there was a surgical delay.Doi- (b)(6) 2024 dor- (b)(6) 2024 affected side- right hip.
Additional Manufacturer Narrative
Product complaint # (b)(4).Investigation summary: no device associated with this report was received for examination.Product description: bi mentum altrx lnr 41 22.Product code: 122122041.Lot no: 3985257.Quantity of manufactured: (b)(4).Date of manufacturing: 07-nov-2022.Expiry date: 31-oct-2027.As part of our company quality system process, all devices are manufactured, inspected, and distributed to approved specifications.Additional complaint information monitoring for potential safety signals will be conducted through complaint trending as part of the post-market surveillance.If additional information is made available, the investigation will be updated as applicable.Device history lot: product description: bi mentum altrx lnr 41 22.Product code: 122122041.Lot no: 3985257.Quantity of manufactured: (b)(4).Date of manufacturing: 07-nov-2022.Expiry date: 31-oct-2027.Device history review: a manufacturing record evaluation was performed for the finished device, and no non-conformances / manufacturing irregularities were identified.
Event or Problem Description
Additional information was received: was there a surgical delay? if yes, what is the duration of the delay? there was no surgical delay.What is the reason for revision? infection.Was the patient experiencing any adverse symptoms/consequences that led to the revision surgery? infection.Was there an infection that lead to the washout? yes.

• Brand Name: BI MENTUM ALTRX LNR 41 22
• Common Device Name: HIP IMPLANT - ACETABULAR LINER
• Manufacturer (Section D): DEPUY IRELAND - 3015516266; loughbeg ringaskiddy co.; cork ; EI
• Manufacturer (Section G): LEEDS MFG & MATERIAL WAREHOUSE; st anthonys road; leeds
• Manufacturer Contact: kate karberg ; 700 orthopaedic dr.; warsaw, IN 46581-0988 ; 3035526892
• MDR Report Key: 19280377
• Report Number: 1818910-2024-10174
• Device Sequence Number: 17726236
• Product Code: LZO
• UDI-Device Identifier: 10603295525356
• UDI-Public: 10603295525356
• Combination Product (Y/N): N
• Initial Reporter State: IN
• Initial Reporter Country: US
• PMA/510(K) Number: K203532
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2024
• Device Explanted Year: 2024
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 05/08/2024

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?: No
• Operator of Device: Health Professional
• Device Catalogue Number: 122122041
• Device Lot Number: 3985257
• 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: 04/28/2024
• Supplement Date Received by Manufacturer: 05/13/2024
• Initial Report FDA Received Date: 05/09/2024
• Supplement Report FDA Received Date: 05/14/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 11/07/2022
• 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: ARTICUL/EZE BALL 22.225+4 NK; PINNACLE DM LINER 48_41
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 80 YR
• Patient Sex: Female