MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US AML HIGH OFFSET LG STAT 13.5MM; AML IMPLANT : HIP FEMORAL STEM

Model Number	1554-03-135
Medical Device Problem Codes	Corroded (1131); Degraded (1153)
Health Effect - Clinical Codes	Edema (1820); Foreign Body Reaction (1868); Tissue Damage (2104); No Code Available (3191)
Date of Event	03/04/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).Initial reporter occupation: lawyer.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
After review of medical records, the patient was revised on (b)(6) 2020.Operative notes reported that upon entering the joint capsule, brown-tinged fluid was encountered consistent with metallosis.There was significant metallosis and caking of black material were note surrounding the trunnion.Doi: (b)(6) 2009; dor: (b)(6) 2020; right hip.The patient has bilateral hip implants, please see (b)(4) for the left hip.
Additional Manufacturer Narrative
Product complaint (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.H10 additional narrative: corrected: h6 (device).

• Brand Name: AML HIGH OFFSET LG STAT 13.5MM
• Common Device Name: AML IMPLANT : HIP FEMORAL STEM
• Manufacturer (Section D): DEPUY ORTHOPAEDICS INC US; 700 orthopaedic drive; warsaw IN 46581 0988
• MDR Report Key: 10309991
• Report Number: 1818910-2020-16587
• Device Sequence Number: 3370659
• Product Code: JDI
• UDI-Device Identifier: 10603295058441
• UDI-Public: 10603295058441
• Combination Product (Y/N): N
• Initial Reporter State: CO
• Initial Reporter Country: US
• PMA/510(K) Number: K012364
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2009
• Reporter Type: Manufacturer
• Report Source: consumer,other
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 07/09/2020

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 Model Number: 1554-03-135
• Device Catalogue Number: 155403135
• Device Lot Number: C25C61000
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 07/09/2020
• Supplement Date Received by Manufacturer: 08/27/2020
• Initial Report FDA Received Date: 07/22/2020
• Supplement Report FDA Received Date: 08/28/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: AML HIGH OFFSET LG STAT 13.5MM; ARTICULEZE M HEAD 36MM +1.5; PINNACLE 100 ACET CUP 54MM; PINNACLE MTL INS NEUT36IDX54OD
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 79 YR