MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US PROSTALAC HIGH 105MM STEM SZ1; MISCELLANEOUS JOINT IMPLANTS : PROSTALAC

Catalog Number	154106000
Medical Device Problem Code	Corroded (1131)
Health Effect - Clinical Code	Unspecified Infection (1930)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
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.D4: udi: as the catalog/model number was not provided, the (01)gtin is not available.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
Thayer school of engineering at dartmouth first report of retrievals for statement of work 10 for q1 of 2025.Dartmouth is the research location, and not the facility of placement.A depuy synthes implant was revised and reviewed for analysis.Reason for revision: removal of prostalac spacer after infection treatment.Reimplantation of final implants.At removal the femoral head showed corrosion.At removal the acetabular liner showed minor yellowing.
Additional Manufacturer Narrative
Product complaint # (b)(4).Investigation summary: no device associated with this report was received for examination.Product description: prostalac high 105mm stem sz1.Product code: 154106000.Lot number: m5526h.Manufacturing date: 30-jan-2024.Expiry date: 31-dec-2033.Quantity manufactured: (b)(4).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: prostalac high 105mm stem sz1.Product code: 154106000.Lot number: m5526h.Manufacturing date: 30-jan-2024.Expiry date: 31-dec-2033.Quantity manufactured: (b)(4).Device history review: a manufacturing record evaluation was performed for the finished device, and no non-conformances / manufacturing irregularities were identified.Added: d10 concomitant.

• Brand Name: PROSTALAC HIGH 105MM STEM SZ1
• Common Device Name: MISCELLANEOUS JOINT IMPLANTS : PROSTALAC
• Manufacturer (Section D): DEPUY ORTHOPAEDICS INC US; 700 orthopaedic drive; warsaw IN 46581 0988
• Manufacturer (Section G): JTE WARSAW MFG SITE; 700 orthopaedic drive; warsaw IN 46582
• Manufacturer Contact: kate karberg ; 700 orthopaedic dr.; warsaw, IN 46581 ; 3035526892
• MDR Report Key: 21987161
• Report Number: 1818910-2025-07430
• Device Sequence Number: 17221383
• Product Code: LPH
• UDI-Device Identifier: 10603295057789
• UDI-Public: (01)10603295057789(17)331231(10)M5526H
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: H000004
• 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: Other,Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 05/08/2025

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 Catalogue Number: 154106000
• Device Lot Number: M5526H
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 04/15/2025
• Supplement Date Received by Manufacturer: 05/28/2025
• Initial Report FDA Received Date: 05/08/2025
• Supplement Report FDA Received Date: 05/29/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 01/30/2024
• 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: 12/14 ARTICUL 40MM M SPEC-2.; ALTRX +4 NEUT 40IDX58OD.
• Patient Sex: Unknown