MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US AML SM STATURE 10.5MM; AML IMPLANT : HIP FEMORAL STEM

Catalog Number	155401105
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Inflammation (1932); Pain (1994); Discomfort (2330); Test Result (2695)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Product complaint #: (b)(4).If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.Concomitant medical products: articuleze m head 36mm +5 hip femoral head.Pinnacle mtl ins neut36idx52od hip acetabular liner.Unknown hip pinnacle acetabular cup.Aml sm stature 10.5mm hip femoral stem.Initial reporter occupation: non-healthcare professional ¿ attorney.
Event or Problem Description
Litigation papers allege: on or about (b)(6) 2007, patient was implanted with a depuy pinnacle mom hip implant on her right side.The implant has caused metal ions and particles to be released into her blood, tissue, and bone surrounding the implant.She has also been experiencing severe pain, discomfort and inflammation in her right thigh and groin, as well as a popping and snapping sensation in her hip joint when walking or moving to and from a sitting position.Patient will likely need to undergo revision surgery.Doi: (b)(6) 2007; dor: none reported; (right hip).
Additional Manufacturer Narrative
Depuy synthes is submitting this report pursuant to the provision of 21 cfr, part 803.The report may be based on the information which depuy synthes has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy synthes or its employees that the report constitutes an admission that the device, depuy synthes, or its employees caused or contributed to the potential event described in this report.H10 additional 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.Device history lot - bg5je1000.Device history batch - null.Device history review - no related deviations or anomalies identified.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 10.5MM
• 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: 8045711
• Report Number: 1818910-2018-74764
• Device Sequence Number: 1625256
• Product Code: JDI
• UDI-Device Identifier: 10603295058205
• UDI-Public: 10603295058205
• Combination Product (Y/N): N
• Initial Reporter State: KY
• Initial Reporter Country: US
• PMA/510(K) Number: K012364
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2007
• Reporter Type: Manufacturer
• Report Source: other
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 10/11/2018

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: 155401105
• Device Lot Number: BG5JE1000
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 10/11/2018
• Supplement Date Received by Manufacturer: 10/23/2019
• Initial Report FDA Received Date: 11/07/2018
• Supplement Report FDA Received Date: 10/29/2019
• 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: Other