MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US AML SM STATURE 15.0MM; AML IMPLANT : HIP FEMORAL STEM

Model Number	1554-01-150
Medical Device Problem Codes	Corroded (1131); Degraded (1153)
Health Effect - Clinical Codes	Edema (1820); Skin Irritation (2076); Tissue Damage (2104); No Code Available (3191)
Date of Event	08/01/2017
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 patient was revised to address unstable revision, right total hip, with mri diagnosis of complete evulsion of hip girdle musculature.Revision notes reported that she has dislocated her hip twice.Mri preop to this surgery showed that she had no connection of her musculature to the greater trochanter and, therefore, because of history of dislocation and the need for a hip abductor brace 24 hours a day, it was decided she should have conversion to a constrained liner in her acetabulum and re-repair of her abductor musculatures.Patient's history of illness reported that she has corrosion between her trunnion in her femoral head causing lots of irritation from metal debris and fluid secretion around the hip.Doi: (b)(6) 2016.Dor: (b)(6) 2017; (right hip).Please see (b)(4) for the 1st revision.
Additional Manufacturer Narrative
Depuy synthes is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on information which depuy synthes been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy as not synthes or its employees that the report constitutes an admission that the device, depuy synthes, or its employees caused or contributed to the potential event described in this report.H10 additional 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.Device history lot: null.Device history batch: null.Device history review: null.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

• Brand Name: AML SM STATURE 15.0MM
• 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: 9871672
• Report Number: 1818910-2020-09013
• Device Sequence Number: 14248973
• Product Code: LPH
• UDI-Device Identifier: 10603295058250
• UDI-Public: 10603295058250
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K012364
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• Device Explanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: consumer,other
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 03/03/2020

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: 1554-01-150
• Device Catalogue Number: 155401150
• Device Lot Number: EB4EW1000
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 03/03/2020
• Supplement Date Received by Manufacturer: 04/30/2020
• Initial Report FDA Received Date: 03/24/2020
• Supplement Report FDA Received Date: 05/01/2020
• 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: 74 YR