MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US AML 12.0 MMA 6.3 5/8 STD 12/14; HIP FEMORAL STEM

Catalog Number	155703000
Medical Device Problem Codes	Adverse Event Without Identified Device or Use Problem (2993); Insufficient Device Problem Information (3190)
Health Effect - Clinical Codes	Abscess (1690); Unspecified Infection (1930); Inflammation (1932); Pain (1994); Distress (2329); Injury (2348)
Date of Event	04/01/2011
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
Alleges device failed causing injuries, infection post-revision and bone damage.After the review of medical records for mdr reportability, it was reported that the patient was revised to address infection.Revision notes reported a lot of pus, greater trochanter was very soft and cracked, and cracked femoral shaft.Clinical notes reported psoas abscess, pain, distress and ambulation difficulties.Laboratory result shows metal ion levels above 7ppb.Doi: (b)(6) 2004; dor: (b)(6) 2011; left hip.
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 will be filed as appropriate.
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.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

• Brand Name: AML 12.0 MMA 6.3 5/8 STD 12/14
• Common Device Name: HIP FEMORAL STEM
• Manufacturer (Section D): DEPUY ORTHOPAEDICS INC US; 700 orthopaedic drive; warsaw IN 46581 0988
• MDR Report Key: 7163422
• Report Number: 1818910-2018-50137
• Device Sequence Number: 13947865
• Product Code: LPH
• UDI-Device Identifier: 10603295059240
• UDI-Public: 10603295059240
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K953694
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2004
• Device Explanted Year: 2011
• Reporter Type: Manufacturer
• Report Source: consumer,other
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 12/05/2017

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: 12/13/2006
• Device Catalogue Number: 155703000
• Device Lot Number: V79GF1006
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 12/05/2017
• Supplement Date Received by Manufacturer: 08/01/2018; 12/09/2019
• Initial Report FDA Received Date: 01/04/2018
• Supplement Report FDA Received Date: 08/27/2018; 01/06/2020
• 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: 53 YR
• Patient Weight: 77