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	Biocompatibility (2886)
Health Effect - Clinical Codes	Inflammation (1932); Pain (1994); Discomfort (2330); Test Result (2695); No Code Available (3191)
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
Litigation papers allege after patient's surgery, friction and wear between the cobalt-chromium metal head and cobalt-chromium liner caused large amounts of toxic cobalt-chromium metal ions and particles to be released into patient's blood and tissue and bone surrounding the implant.It is also alleged as a result, patient has been experiencing severe pain and discomfort and inflammation in her right thigh and groin.It is further alleged patient also experiences a popping and snapping sensation in her hip-joint when walking or moving to and from a sitting position.Update 01 may 2018: ppf and sticker sheets.Ppf has no new allegations reported.Updated the product information of the liner.Added date of birth, lawyer and law firm in the facility name.An impacted product record for the head and stem was added due to previously alleged elevated metal ion level.
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 10.5MM
• 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: 7991510
• Report Number: 1818910-2018-73116
• Device Sequence Number: 19249879
• Product Code: JDI
• UDI-Device Identifier: 10603295058205
• UDI-Public: 10603295058205
• Combination Product (Y/N): N
• Initial Reporter State: CO
• 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
• Report Date (Section B): 10/01/2018

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: A2EAH1000
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 10/01/2018
• Supplement Date Received by Manufacturer: 12/19/2018
• Initial Report FDA Received Date: 10/22/2018
• Supplement Report FDA Received Date: 12/27/2018
• 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: Required Intervention