MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US AML LG STATURE 16.5MM; AML IMPLANT : HIP FEMORAL STEM

Catalog Number	155402165
Medical Device Problem Code	Biocompatibility (2886)
Health Effect - Clinical Codes	Foreign Body Reaction (1868); Unspecified Infection (1930); Pain (1994); Tissue Damage (2104); Discomfort (2330); Injury (2348); Test Result (2695)
Date of Event	12/11/2017
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.(b)(6).(b)(4).
Event or Problem Description
Litigation alleges pain and discomfort.Update ad 21 sep 2018 in addition to what was previously alleged, litigation alleges metallosis, mental anguish, suffering, emotional distress, injury, painful infection, and excessive levels of chromium and cobalt in the blood.
Additional Manufacturer Narrative
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.If information is obtained that was not available for the initial medwatch , a follow-up medwatch, a follow-up medwatch will be filed as appropriate.

• Brand Name: AML LG STATURE 16.5MM
• 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: 7975259
• Report Number: 1818910-2018-72784
• Device Sequence Number: 202199
• Product Code: JDI
• UDI-Device Identifier: 10603295058380
• UDI-Public: 10603295058380
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K012364
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2006
• Device Explanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: consumer,other
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 09/21/2018

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: 155402165
• Device Lot Number: ZF3AC1000
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 09/21/2018
• Supplement Date Received by Manufacturer: 12/10/2018; 08/22/2019
• Initial Report FDA Received Date: 10/17/2018
• Supplement Report FDA Received Date: 12/10/2018; 08/29/2019
• 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: 47 YR
• Patient Weight: 129