MAUDE Adverse Event Report: DEPUY INTERNATIONAL LTD. 8010379 AML 13.5 MMA 6.3 5/8 STD 12/14; AML IMPLANT : HIP FEMORAL STEM

Catalog Number	155704000
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
(b)(4).If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.Concomitant med products: articuleze m head 36mm +12 hip femoral head; pinnacle mtl ins neut36idx54od hip acetabular liner; unknown hip acetabular cup; aml 13.5 mma 6.3 5/8 std 12/14 hip femoral stem.
Event or Problem Description
Litigation papers allege that after the surgery, friction and wear between the cobalt-chromium metal head and cobalt-chromium metal 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.As a result, patient has been experiencing severe pain and discomfort and inflammation in his right and left thigh and groin.He also experiences a popping and snapping sensation in his hip-joint when walking or moving to and from a sitting position.It is further alleged that the patient will likely need to undergo revision surgery to replace the implant.Doi: (b)(6) 2003 - dor: none reported (right hip); doi: (b)(6) 2003 - dor: none reported (left hip).Patient is resident of (b)(6).Update ad 1 may 2018: (b)(4) has been re-opened under (b)(4) due to the receipt of ppf and sticker sheets.Ppf has no allegation and no revision reported.The unknown depuy pinnacle hip that was reported in the wpc was changed to pinnacle metal liner.Added head and stem due to a large amount of toxic cobalt chromium.Updated dob and added law firm in the facility name.The patient underwent bilateral total hip arthroplasty and the right hip was captured under (b)(4).Doi: (b)(6) 2003, dor: none reported (left hip).
Additional Manufacturer Narrative
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.  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.

• Brand Name: AML 13.5 MMA 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: 8045577
• Report Number: 1818910-2018-74736
• Device Sequence Number: 1786961
• Product Code: LPH
• UDI-Device Identifier: 10603295059257
• UDI-Public: 10603295059257
• 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: 2003
• Reporter Type: Manufacturer
• Report Source: other
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 10/10/2018

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: 155704000
• Device Lot Number: XN8FL1002
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 10/10/2018
• Supplement Date Received by Manufacturer: 11/08/2018
• Initial Report FDA Received Date: 11/07/2018
• Supplement Report FDA Received Date: 11/08/2018
• 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