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

Catalog Number	155401165
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Foreign Body Reaction (1868); Unspecified Infection (1930); Pain (1994); Test Result (2695)
Date of Event	01/09/2012
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Product complaint # = > (b)(4).Initial reporter occupation: lawyer.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
Litigation alleges that patient experienced severe pain over a period of time, which hindered her ability to walk and required various pain medications.Her physician detected high metal levels in her blood.Doi: (b)(6) 2008 - dor: none reported (left hip).**patient is a resident of (b)(6) update: 10/10/2012 pfs was received from legal, medical records were received from legal.There is no new information that would change the existing mdr decision.Records are available for further review.Update ad 10 sep 2019.(b)(4) has been reopened under (b)(4) due to receipt of ppf and sticker sheets via cd shipment ad 25 sep.Ppf alleges infection requiring iv antibiotics, metal wear, metallosis and elevated metal ions.Doi: (b)(6) 2008 - dor: not revised (left hip).
Additional Manufacturer Narrative
Product complaint # (b)(4).Investigation summary = > no device associated with this report was received for examination.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.Depuy considers the investigation closed.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 will be filed as appropriate.

• Brand Name: AML SM 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: 9140215
• Report Number: 1818910-2019-106998
• Device Sequence Number: 3046350
• Product Code: JDI
• UDI-Device Identifier: 10603295058267
• UDI-Public: 10603295058267
• Combination Product (Y/N): N
• Initial Reporter State: AL
• Initial Reporter Country: US
• PMA/510(K) Number: K012364
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2008
• Reporter Type: Manufacturer
• Report Source: other
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 09/10/2019

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 Expiration Date: 08/30/2018
• Device Catalogue Number: 155401165
• Device Lot Number: X2LGNB000
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 09/10/2019
• Supplement Date Received by Manufacturer: 12/10/2019
• Initial Report FDA Received Date: 10/01/2019
• Supplement Report FDA Received Date: 01/08/2020
• 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: Hospitalization; Required Intervention
• Patient Age: 56 YR
• Patient Weight: 68