MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US AML HIGH OFFSET LG STAT 16.5MM; AML IMPLANT : HIP FEMORAL STEM

Catalog Number	155403165
Medical Device Problem Code	Appropriate Device Problem Term/Code Not Available (3191)
Health Effect - Clinical Codes	Hypersensitivity/Allergic reaction (1907); Pain (1994); Tissue Damage (2104); Injury (2348)
Date of Event	11/16/2010
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).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 by legal that patient was revised on (b)(6) 2010 and the following was performed during surgery debridement of the trochanter bursa, hip arthrotomy, debridement of fibrous tissue surrounding the hip, slight metallosis.Surgery was well tolerated.Prior to revision patient experienced burning pain, loosening of the prosthesis vs abductor muscle injury, bilateral sciatalgia and bursitis.Following surgery the pain persisted and on (b)(6) 2010 patient was revised which included a conversion from metal to polyethylene implant.A very thick pseudo capsule and effusion were noted during surgery.The surgery was tolerated well but there is a hip metal hypersensitivity.Ad (b)(6) 2018: translated medical records received.After review of the medical records for mdr reportability, the patient was revised to address metal hypersensitivity.Clinical notes reported of pain, slight metallosis, bursitis, elevated metal ions, and loosening of abductor muscle injury.
Additional Manufacturer Narrative
(b)(4).Investigation summary: no device associated with this report was received for examination.The information received will be retained for potential series investigations if triggered by trend analysis, post market surveillance, or other events within the quality system.Depuy considers the investigation closed.Should additional information be received, the information will be reviewed and the investigation will be re-opened as necessary.If information is obtained that was not available for the initial medwatch , a follow-up medwatch, a follow-up medwatch will be filed as appropriate.

• Brand Name: AML HIGH OFFSET LG STAT 16.5MM
• Common Device Name: AML IMPLANT : HIP FEMORAL STEM
• Manufacturer (Section D): DEPUY ORTHOPAEDICS INC US; 700 orthopaedic drive; warsaw IN 46582 0988
• MDR Report Key: 7302258
• Report Number: 1818910-2018-54222
• Device Sequence Number: 16706573
• Product Code: JDI
• UDI-Device Identifier: 10603295058465
• UDI-Public: 10603295058465
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: K012364
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2009
• Device Explanted Year: 2010
• Reporter Type: Manufacturer
• Report Source: consumer,foreign
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 01/31/2018

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: 12/10/2017
• Device Catalogue Number: 155403165
• Device Lot Number: B79GG1000
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 01/31/2018
• Supplement Date Received by Manufacturer: 03/16/2018; 06/15/2018
• Initial Report FDA Received Date: 02/28/2018
• Supplement Report FDA Received Date: 03/28/2018; 06/22/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 52 YR