MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US AML SM STATURE 12.0MM; AML IMPLANT : HIP FEMORAL STEM

Catalog Number	155401120
Medical Device Problem Code	Biocompatibility (2886)
Health Effect - Clinical Code	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.
Event or Problem Description
Litigation alleges the patient suffers from pain, discomfort, inflammation, and large amounts of toxic cobalt chromium metal ions and particles to be released into the blood, tissue, and bone.Update ad 1 may 2018: (b)(4) has been re-opened under (b)(4) due to the receipt of ppf and sticker sheets.There are new indications that the patient is bilateral, which is why this complaint was created for the right hip.There are no allegations or revision reported.Doi: (b)(6) 2007; dor: none reported; (right hip).(b)(4) for left hip.
Additional Manufacturer Narrative
(b)(4).
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, a follow-up medwatch will be filed as appropriate.

• Brand Name: AML SM STATURE 12.0MM
• Common Device Name: AML IMPLANT : HIP FEMORAL STEM
• Manufacturer (Section D): DEPUY ORTHOPAEDICS INC US; 700 orthopaedic drive; warsaw IN 46582 0988
• MDR Report Key: 7946446
• Report Number: 1818910-2018-71720
• Device Sequence Number: 19025151
• Product Code: JDI
• UDI-Device Identifier: 10603295058229
• UDI-Public: 10603295058229
• 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: 2007
• Reporter Type: Manufacturer
• Report Source: consumer,other
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 09/18/2018

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: 155401120
• Device Lot Number: A3OAC1000
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 09/18/2018
• Supplement Date Received by Manufacturer: 09/18/2018; 10/24/2018
• Initial Report FDA Received Date: 10/09/2018
• Supplement Report FDA Received Date: 10/09/2018; 10/24/2018
• 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: Other