MAUDE Adverse Event Report: DEPUY INTERNATIONAL LTD. 8010379 AML LG STATURE 13.5MM; HIP FEMORAL STEM

Catalog Number	155402135
Medical Device Problem Code	Loose or Intermittent Connection (1371)
Health Effect - Clinical Codes	Hypersensitivity/Allergic reaction (1907); Pain (1994); Injury (2348); Inadequate Osseointegration (2646)
Date of Event	01/13/2014
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
Patient was revised to address detachment of the femoral stem and reaction to metal.Operative notes reported of brownish tissue around the top and bottom parts of the capsule, porous bone probable secondary to a reaction with the metallic lesions.Clinic visits reported of pain since fall and reaction to metal.Mri showed fluid around the tight hip.Doi: (b)(6) 2009; dor: (b)(6) 2014; right hip asr.Patient is bilateral.See (b)(4) for the left hip.
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-(b)(4).Ongoing post market surveillance is conducted per our procedures for this product.Device history lot: null.Device history batch: null.Device history review: null.

• Brand Name: AML LG STATURE 13.5MM
• Common Device Name: HIP FEMORAL STEM
• Manufacturer (Section D): DEPUY INTERNATIONAL LTD. 8010379; st. anthony's road; leeds LS11 8DT; UK LS11 8DT
• MDR Report Key: 7361525
• Report Number: 1818910-2018-55863
• Device Sequence Number: 173650
• Product Code: JDI
• UDI-Device Identifier: 10603295058366
• UDI-Public: 10603295058366
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K012364
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2009
• Device Explanted Year: 2014
• Reporter Type: Manufacturer
• Report Source: consumer,foreign,other
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 02/28/2018

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 Catalogue Number: 155402135
• Device Lot Number: DW1D51000
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 02/28/2018
• Supplement Date Received by Manufacturer: 07/18/2018
• Initial Report FDA Received Date: 03/22/2018
• Supplement Report FDA Received Date: 08/17/2018
• 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: 54 YR