MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC 1818910 AML LG STATURE 12.0MM; AML IMPLANT : HIP FEMORAL STEM

Catalog Number	155402120
Medical Device Problem Code	Appropriate Device Problem Term/Code Not Available (3191)
Health Effect - Clinical Codes	Pain (1994); Tissue Damage (2104); Discomfort (2330); Injury (2348)
Date of Event	12/15/2015
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
Initial procedure, (b)(6) 2008 : left total hip replacement.Patient was originally implanted with size 46 asr unipolar femoral component, asrtaper sleeve adaptor and size 52 asr total acetabular component.Preoperative diagnosis-severe left coxarthrosis (prior to (b)(6) 2008 surgery).It was reported by legal that the patient was revised on (b)(6) 2015 patient had a total left hip revision.The pre-op diagnosis was a pseudotumor and contained bone loss (left femur and left acetabulum).The surgery involved removal of the left hip pseudotumor, revision of the acetabular cavity, total left hip replacement.Allograft-left acetabulum and left femur.(b)(6) 2018: medical records and translated document received.After review of medical records for mdr reportability, it was indicated that the patient was revised due to pseudotumor type tissue reaction to a total left hip replacement with contained bone loss.The revision notes report that when they opened the junction between the scar tissue and the posterior part of the greater trochanter, a large amount of greenish serous fluid was found.An abnormal tissue reaction with greenish hyperplastic tissue in the back of the hip prosthesis and brownish hyperplastic tissue in front was also observed.Presence of metallosis at the junction between the head, neck and femoral prosthesis was also noted.It was observed that on the posterior side of the femoral prosthesis, there was an enormous cavity which required an allograft.It was also reported that there were some contained bone loss in the anterior and inferior areas of the acetabular component and these areas were cleaned with a curette to remove poor-quality tissue.Clinic visits show that patient had intermittent pain, discomfort and metallosis.Ultrasound confirms fluid buildup.Lab results also indicate elevated c-reactive protein, chromium and cobalt ion levels.
Additional Manufacturer Narrative
If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.Product complaint # :(b)(4).Investigation summary the asr platform was voluntarily recalled from the market in august 2010, and the asr product codes are now considered inactive.Further investigation of this individual incident will not be undertaken.The investigation regarding the root cause(s) and/or corrective actions was conducted under mdd capa-001226.Ongoing post market surveillance is conducted per our procedures for this product.

• Brand Name: AML LG STATURE 12.0MM
• Common Device Name: AML IMPLANT : HIP FEMORAL STEM
• Manufacturer (Section D): DEPUY ORTHOPAEDICS INC 1818910; 700 orthopaedic drive; warsaw IN 46582 0988
• MDR Report Key: 7352390
• Report Number: 1818910-2018-55534
• Device Sequence Number: 16324573
• Product Code: JDI
• UDI-Device Identifier: 10603295058342
• UDI-Public: 10603295058342
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: K012364
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2008
• Device Explanted Year: 2015
• Reporter Type: Manufacturer
• Report Source: consumer,foreign,other
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 02/23/2018

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: 08/29/2011
• Device Catalogue Number: 155402120
• Device Lot Number: A3DB41000
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 02/23/2018
• Supplement Date Received by Manufacturer: 07/18/2018
• Initial Report FDA Received Date: 03/20/2018
• Supplement Report FDA Received Date: 08/16/2018
• 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