MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS, INC. 1818910 AML HIGH OFFSET LG STAT 15.0MM; AML IMPLANT : HIP FEMORAL STEM

Model Number	1554-03-150
Medical Device Problem Code	Corroded (1131)
Health Effect - Clinical Codes	Host-Tissue Reaction (1297); Cardiac Arrest (1762); Pain (1994); Loss of Range of Motion (2032); Renal Failure (2041); Test Result (2695); No Code Available (3191)
Date of Event	12/21/2011
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Product complaint # (b)(4).If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.Concomitant medical products: articul/eze ball 32 +9 bl hip femoral head; pinn mar +4 10d 32idx62od hip acetabular liner; pinnacle sector ii cup 62mm hip acetabular cup; aml high offset lg stat 15.0mm hip femoral stem.Initial reporter occupation: non-healthcare professional ¿ patient (maude report).
Event or Problem Description
Maude report received stating that patient had developed limited movement issues and pain.The parts were cobalt and chromium.He had kidney failure, heart attack, numerous tumors near his hip replacement and cobalt and chromium poisoning.Doi: 2006; dor: n/a; unknown hip.
Additional Manufacturer Narrative
(b)(4).
Additional Manufacturer Narrative
Product complaint #: (b)(4).Investigation summary: no device associated with this report was received for examination.A search of the depuy nonconformance (nc) quality system found no nc¿s associated with this product/lot combination.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.Device history lot: a search of the depuy nonconformance (nc) quality system found no nc¿s associated with this product/lot combination.Device history review: a search of the depuy nonconformance (nc) quality system found no nc¿s associated with this product/lot combination.

• Brand Name: AML HIGH OFFSET LG STAT 15.0MM
• Common Device Name: AML IMPLANT : HIP FEMORAL STEM
• Manufacturer (Section D): DEPUY ORTHOPAEDICS, INC. 1818910; 700 orthopaedic drive; warsaw IN 46581 0988
• MDR Report Key: 8075181
• Report Number: 1818910-2018-75664
• Device Sequence Number: 1721051
• Product Code: JDI
• UDI-Device Identifier: 10603295058458
• UDI-Public: 10603295058458
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K012364
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2006
• Device Explanted Year: 2018
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: consumer,other
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 10/17/2018

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 Model Number: 1554-03-150
• Device Catalogue Number: 155403150
• Device Lot Number: ZN6G61000
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 10/17/2018
• Supplement Date Received by Manufacturer: 02/11/2019; 05/12/2021
• Initial Report FDA Received Date: 11/15/2018
• Supplement Report FDA Received Date: 02/18/2019; 05/12/2021
• 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: Other