MAUDE Adverse Event Report: DEPUY INTERNATIONAL LTD. 8010379 AML 12.0 STD 6.3 5/8 STD 12/14; AML IMPLANT : HIP FEMORAL STEM

Catalog Number	155403000
Medical Device Problem Code	Loss of Osseointegration (2408)
Health Effect - Clinical Codes	Pain (1994); Osteolysis (2377); Inadequate Osseointegration (2646); No Code Available (3191)
Date of Event	12/28/2018
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
The patient was revised to address pain, osteolysis and loosening of the stem at bone to implant interface.
Additional Manufacturer Narrative
(b)(4).Investigation summary: no device associated with this report was received for examination.Depuy synthes considers the investigation closed at this time.Should additional information be received, the information will be reviewed and the investigation will be re-opened as necessary.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 12.0 STD 6.3 5/8 STD 12/14
• Common Device Name: AML IMPLANT : HIP FEMORAL STEM
• Manufacturer (Section D): DEPUY INTERNATIONAL LTD. 8010379; st. anthony's rd; leeds LS11 8 DT; UK LS11 8 DT
• MDR Report Key: 8265262
• Report Number: 1818910-2019-81679
• Device Sequence Number: 1578212
• Product Code: LPH
• UDI-Device Identifier: 10603295058434
• UDI-Public: 10603295058434
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: K953694
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2008
• Device Explanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 12/28/2018

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: 155403000
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 12/28/2018
• Supplement Date Received by Manufacturer: 01/30/2019
• Initial Report FDA Received Date: 01/21/2019
• Supplement Report FDA Received Date: 01/31/2019
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 75 YR