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

Catalog Number	155402135
Medical Device Problem Code	Biocompatibility (2886)
Health Effect - Clinical Codes	Tissue Damage (2104); Test Result (2695); No Code Available (3191)
Date of Event	05/02/2012
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.Occupation: attorney.(b)(4).
Event or Problem Description
(b)(4).Reason for original complaint: patient was revised to address metallosis.Update: 5/29/13 - litigation papers received.Litigation alleges fluid collection.There is no additional information that would affect the outcome of this investigation.Update: 6/12/2013: pfs was received from legal, medical records were received from legal.There is no new information that would change the existing mdr decision.Records are available for further review.Update ad 14 aug 2018: (b)(4) has been reopened under (b)(4) due to the receipt of ppf and sticker sheets record.In addition to what was previously alleged, ppf alleges elevated metal ions.Stem was added due to alleged elevated metal ions.
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.

• Brand Name: AML LG STATURE 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: 8599978
• Report Number: 1818910-2019-93163
• Device Sequence Number: 11347676
• Product Code: JDI
• UDI-Device Identifier: 10603295058366
• UDI-Public: 10603295058366
• 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: 2007
• Reporter Type: Manufacturer
• Report Source: consumer,other
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 04/12/2019

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 Catalogue Number: 155402135
• Device Lot Number: AW6F61000
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 04/12/2019
• Supplement Date Received by Manufacturer: 11/01/2019
• Initial Report FDA Received Date: 05/10/2019
• Supplement Report FDA Received Date: 11/06/2019
• 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: 59 YR
• Patient Weight: 91