MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US AML LG STATURE 21.0MM; AML IMPLANT : HIP FEMORAL STEM

Catalog Number	155402210
Medical Device Problem Code	Loss of or Failure to Bond (1068)
Health Effect - Clinical Codes	Inadequate Osseointegration (2646); Malunion of Bone (4529)
Date of Event	05/06/2021
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 medwatch, a follow-up medwatch will be filed as appropriate.
Event or Problem Description
It was reported that on (b)(6) 2020 patient was re-implanted with depuy poly liner, ceramic head and aml stem.During extraction and re-implantation of the depuy aml stem, an intraoperative perforation fracture of the distal femur occurred.The patient required a femoral strut allograft with 5 cerclage cables and a greater trochanter plate to treat (all competitor products).A ct scan on (b)(6) 2021 reports a periprosthetic fracture non-union of the patient's left femur, involving cerclage cables and a greater trochanter hook (manufacturer not provided).There is also no information on when the fracture occurred or when it was initially repaired.All left total hip products were still present.On (b)(6) 2021, patient's left hip was revised to address a loose femoral stem implant secondary to a previous periprosthetic and greater trochanter femur fractures, that had not properly healed and ultimately failed with non-union and loosening of the femur implant.Stem and head were revised to a reclaim stem and head, while retaining the existing cup, screws, and liner.Doi: (b)(6) 2020; dor: (b)(6) 2021; left hip.
Additional Manufacturer Narrative
Product complaint # (b)(4).Investigation summary: no device associated with this report was received for examination.The product investigation found no evidence suspecting an error in the manufacturing or material that would be a contributing factor in the reported allegation(s).A records evaluation (mre) was not performed.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: the product investigation found no evidence suspecting an error in the manufacturing or material that would be a contributing in the reported allegation(s).A manufacturing records evaluation (mre) was not performed.

• Brand Name: AML LG STATURE 21.0MM
• Common Device Name: AML IMPLANT : HIP FEMORAL STEM
• 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 orthpaedic dr.; warsaw, IN 46581 ; 3035526892
• MDR Report Key: 21253167
• Report Number: 1818910-2025-01612
• Device Sequence Number: 12785675
• Product Code: LPH
• UDI-Device Identifier: 10603295058410
• UDI-Public: (01)10603295058410(17)221031(10)291719A
• Combination Product (Y/N): N
• Initial Reporter State: MO
• Initial Reporter Country: US
• PMA/510(K) Number: K012364
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Device Explanted Year: 2021
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Other,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup

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 Expiration Date: 10/31/2022
• Device Catalogue Number: 155402210
• Device Lot Number: 291719A
• 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: 01/15/2025
• Supplement Date Received by Manufacturer: 02/03/2025
• Initial Report FDA Received Date: 01/28/2025
• Supplement Report FDA Received Date: 02/04/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 10/11/2012
• 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: DELTA CER HEAD 12/14 36MM +8.5
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 53 YR
• Patient Sex: Male