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

Catalog Number	155401121
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Foreign Body Reaction (1868); Pain (1994); Limited Mobility Of The Implanted Joint (2671); Test Result (2695); No Code Available (3191)
Date of Event	06/18/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Product complaint # (b)(4).Initial reporter occupation: lawyer.(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
After review of medical record, patient was revised to address metal-on-metal total hip arthroplasty with elevated metal ion levels.Revision notes reported that there was some blackening of the pericapsular tissue.Head and liner were removed.Clinical visits reported bilateral hip pain, heterotopic ossification, limited mobility, locking sensation in both hips, metal on metal articulation and finding is consistent with alval.Lab results for metal ions were above 7.Findings from revision: synovial fluid was straw-colored.There was some changes of the synovium consistent with metal wear.No pseudotumor formation was noted.There was no clear evidence of trunnionosis.Doi: (b)(6) 2009 - dor: (b)(6) 2018, (right hip).
Additional Manufacturer Narrative
Product complaint # (b)(4).Investigation summary = > no device associated with this report was received for examination.A worldwide complaint database search found no other related reported incidents against the provided product code/lot number combination since release for distribution.Based on previous investigations, this complication of joint replacement is unlikely to have been the result of a device failing to meet required specifications.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.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

• 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 46582 0988
• MDR Report Key: 8874224
• Report Number: 1818910-2019-100497
• Device Sequence Number: 14100188
• Product Code: LPH
• UDI-Device Identifier: 10603295058236
• UDI-Public: 10603295058236
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K061833
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2009
• Device Explanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: other
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 07/19/2019

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: 155401121
• Device Lot Number: BX9G31000
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 07/19/2019
• Supplement Date Received by Manufacturer: 08/09/2019
• Initial Report FDA Received Date: 08/08/2019
• Supplement Report FDA Received Date: 08/13/2019
• 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: 48 YR