MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US AML LG STATURE 15.0MM; AML IMPLANT : HIP FEMORAL STEM

Catalog Number	155402150
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Unspecified Infection (1930); Pain (1994); Osteolysis (2377); Metal Related Pathology (4530)
Date of Event	12/16/2011
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
Pinnacle implants were implanted in the right hip on (b)(6) 2007.Revised on (b)(6) 2011, femoral osteolysis, infection.Cobalt and chromium are 14 and 9, pain.All implants were removed.Osteotomy was used to remove the aml stem.Prostalac was implanted.Loose cup was noted pre-op, but operative noted indicated it was embedded and there was no indication of loosening.Picc line was placed for treatment of infection.Second stage revision on (b)(6) 2012 ¿ competitor stem placed with pinnacle cup.Doi: (b)(6) 2007, dor: (b)(6) 2011, right hip.
Additional Manufacturer Narrative
Product complaint # (b)(4).Investigation summary : no device associated with this report was received for examination.Product description:- aml lg stature 15.0mm product code:- 155402150 lot no:- a77kfa000 quantity of manufactured:- (b)(4).Date of manufacturing:- dec-2006.Expiry date:-dec-2016, 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:- aml lg stature 15.0mm, product code:- 155402150, lot no:- a77kfa000, quantity of manufactured:- (b)(4), date of manufacturing:- dec-2006, expiry date:-dec-2016.Device history review : a manufacturing record evaluation was performed for the finished device, and no non-conformances / manufacturing irregularities were identified.

• Brand Name: AML LG STATURE 15.0MM
• 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
• Manufacturer Contact: kate karberg ; 700 orthopaedic dr.; warsaw, IN 46581 ; 3035526892
• MDR Report Key: 19624250
• Report Number: 1818910-2024-14088
• Device Sequence Number: 20441474
• Product Code: LPH
• UDI-Device Identifier: 10603295058373
• UDI-Public: (01)10603295058373(10)A77KFA000(17)161217
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K012364
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2007
• Device Explanted Year: 2011
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 06/27/2024

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 Expiration Date: 12/17/2016
• Device Catalogue Number: 155402150
• Device Lot Number: A77KFA000
• 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: 06/18/2024
• Supplement Date Received by Manufacturer: 07/10/2024
• Initial Report FDA Received Date: 06/27/2024
• Supplement Report FDA Received Date: 07/11/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 12/20/2006
• 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: ARTICULEZE M HEAD 36MM +5; PINNACLE 300 ACET CUP 64MM; PINNACLE MTL INS NEUT36IDX64OD
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 61 YR
• Patient Sex: Male