MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS, INC. 1818910 AML HIGH OFFSET LG STAT 13.5MM; AML IMPLANT : HIP FEMORAL STEM

Catalog Number	155403135
Medical Device Problem Code	Corroded (1131)
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: 12/14 articul 40mm m spec+5 hip femoral head; pinnacle mtl ins neut40idx58od hip acetabular liner; unknown hip acetabular cup; aml high offset lg stat 13.5mm hip femoral stem.Initial reporter occupation: non-healthcare professional ¿ attorney.
Event or Problem Description
New unity record created in order to update legacy complaint number (b)(4).Litigation papers allege that corrosion and friction wear caused large amounts of toxic cobalt-chromium metal ions and particles to be released into the patient's blood and tissue and bone surrounding the implant.It is further alleged that the patient has experienced severe pain and discomfort and inflammation in his left thigh and hip area, as well as his groin.Patient has experienced episodes of a grinding and popping sensation in his left hip.Doi: (b)(6) 2007; dor: none reported (left hip).Patient is a resident of (b)(6).Update ad 01 may 2018: (b)(4) has been re-opened under (b)(4) due to the receipt of ppf and sticker sheets.There were no new allegations or revisions reported.Added stem due to previously alleged large amounts of toxic cobalt-chromium metal ions.Added patient's dob, age, law firm and lawyer in the associated contact.Updated part and lot numbers of the impacted products.Doi: (b)(6) 2007; dor: none reported (left hip).
Additional Manufacturer Narrative
Depuy synthes is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on 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.Product complaint # (b)(4).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 HIGH OFFSET LG STAT 13.5MM
• Common Device Name: AML IMPLANT : HIP FEMORAL STEM
• Manufacturer (Section D): DEPUY ORTHOPAEDICS, INC. 1818910; 700 orthopaedic drive; warsaw IN 46581 0988
• MDR Report Key: 8009355
• Report Number: 1818910-2018-73617
• Device Sequence Number: 11107737
• Product Code: JDI
• UDI-Device Identifier: 10603295058441
• UDI-Public: 10603295058441
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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): 10/03/2018

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: 155403135
• Device Lot Number: BW5GL1000
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 10/03/2018
• Supplement Date Received by Manufacturer: 10/30/2019
• Initial Report FDA Received Date: 10/26/2018
• Supplement Report FDA Received Date: 11/11/2019
• 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
• Patient Age: 46 YR