MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US AML 15.0 STD 6.3 5/8 STD 12/14; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED

Catalog Number	155405000
Medical Device Problem Code	Degraded (1153)
Health Effect - Clinical Codes	Foreign Body Reaction (1868); Hypersensitivity/Allergic reaction (1907); Pain (1994); Ambulation or Postural Difficulties (2544); Unspecified Tissue Injury (4559); Swelling/ Edema (4577)
Date of Event	10/07/2012
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Product complaint # (b)(4).E3 initial reporter occupation: lawyer.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
Medical records received ad 18 jun 2024.After review of medical records patient was revised was due to adverse reaction to metal debris right hip.Prior to revision patient mri showed failed pseudotumor but she had a large fluid collection at the trochanter with avulsion of the anterior glutei.Pain has been stable but intermittent in severity and complaints audible grinding.There is a slight limp.Operative notes indicated upon removing the head there was a tremendous amount of metallic, black debris at the trunnion.Doi: (b)(6) 2006.Dor: (b)(6) 2012.Right hip.
Additional Manufacturer Narrative
Product complaint # (b)(4).Investigation summary: no device associated with this report was received for examination.Product description:- aml 15.0 std 6.3 5/8 std 12/14, product code:- 155405000, lot no:- z21ca1000, quantity of manufactured:- (b)(4), date of manufacturing:- 15-aug-2005, expiry date:- 31-jul-2015.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 15.0 std 6.3 5/8 std 12/14, product code:- 155405000, lot no:- z21ca1000, quantity of manufactured:- (b)(4), date of manufacturing:- 15-aug-2005, expiry date:- 31-jul-2015.Device history review : a manufacturing record evaluation was performed for the finished device, and no non-conformances / manufacturing irregularities were identified.

• Brand Name: AML 15.0 STD 6.3 5/8 STD 12/14
• Common Device Name: PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED
• 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 46581-0988 ; 3035526892
• MDR Report Key: 19655664
• Report Number: 1818910-2024-14493
• Device Sequence Number: 12420180
• Product Code: LPH
• UDI-Device Identifier: 10603295058526
• UDI-Public: (01)10603295058526(10)Z21CA1000(17)110609
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K953694
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2006
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Other,Foreign
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 07/02/2024

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: 06/09/2011
• Device Catalogue Number: 155405000
• Device Lot Number: Z21CA1000
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 06/18/2024
• Supplement Date Received by Manufacturer: 07/24/2024
• Initial Report FDA Received Date: 07/02/2024
• Supplement Report FDA Received Date: 07/25/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 08/17/2005
• 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 -2; CANCELLOUS BONE SCREW 6.5X30MM; PINNACLE 100 ACET CUP 54MM; PINNACLE MTL INS NEUT36IDX54OD
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 73 YR
• Patient Sex: Female