MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US 6IN AML SM STATURE 12.0MM; AML IMPLANT : HIP FEMORAL STEM

Model Number	1554-01-121
Medical Device Problem Code	Loss of Osseointegration (2408)
Health Effect - Clinical Codes	Adhesion(s) (1695); Pain (1994); Weakness (2145); Inadequate Osseointegration (2646); No Code Available (3191)
Date of Event	08/28/2017
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
Update oct.5, 2017: litigation record received.Litigation alleges pain, weakness and difficulty with simple living activities.Update feb.21, 2020: after review of medical records, the patient was revised due to wear of articular weight-bearing surface, pain and loosening of the femoral stem.Radiographs showed no signs of loosening and the stem appeared to be spot-welded in several spots.The patient's cobalt chromium levels were elevated.Operative notes indicate that there was a lot of scarring, the stem was rotationally loose.Doi: (b)(6) 2010; dor: (b)(6) 2017; right hip.
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 has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy 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.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: 6IN AML SM STATURE 12.0MM
• 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: 9808392
• Report Number: 1818910-2020-07279
• Device Sequence Number: 654045
• Product Code: LPH
• UDI-Device Identifier: 10603295058236
• UDI-Public: 10603295058236
• Combination Product (Y/N): N
• Initial Reporter State: AL
• Initial Reporter Country: US
• PMA/510(K) Number: K061833
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2010
• Device Explanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: consumer,other
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 01/18/2013

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: 1554-01-121
• Device Catalogue Number: 155401121
• Device Lot Number: EA6CC1000
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 02/21/2020
• Supplement Date Received by Manufacturer: 04/07/2020
• Initial Report FDA Received Date: 03/09/2020
• Supplement Report FDA Received Date: 04/16/2020
• 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: 57 YR