MAUDE Adverse Event Report: DEPUY INTERNATIONAL LTD - 8010379 ASPHERE M SPEC 12/14 40 +8.5; ARTICULEZE HEAD (12/14 TAPER) : HIP METAL FEMORAL HEADS

Catalog Number	136507100
Medical Device Problem Codes	Material Disintegration (1177); Naturally Worn (2988); Insufficient Device Problem Information (3190); Appropriate Device Problem Term/Code Not Available (3191)
Health Effect - Clinical Codes	Host-Tissue Reaction (1297); Pain (1994); Loss of Range of Motion (2032); Distress (2329); Discomfort (2330); Injury (2348); Deformity/ Disfigurement (2360); Limited Mobility Of The Implanted Joint (2671); Not Applicable (3189); No Code Available (3191)
Date of Event	01/02/2018
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
Patient was revised to address hip and groin pain.Doi: (b)(6) 2010; dor: (b)(6) 2018 left hip.
Additional Manufacturer Narrative
(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.
Additional Manufacturer Narrative
Additional narrative: 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
In addition to what was previously alleged, litigation alleges injury, discomfort, loss of mobility, loss of range of motion, disfigurement, emotional distress, difficulty ambulating, mental anguish, metallosis which caused large amount of toxic cobalt and chromium metal ions to be released into the hip capsule, tissues, blood stream, and organs.Doi: (b)(6) 2010; dor: (b)(6) 2018 left hip.
Additional Manufacturer Narrative
(b)(4).
Event or Problem Description
Pfs alleges trunniosis.After review of medical records, patient was revised to address metallosis and adverse tissue reaction with increased metal ions.Revision notes reported of trunnionosis, granular or wear debris within the capsular tissue, some black trunniosis debris at the femoral head and neck junction.There were no lab result for the high metal ions.
Event or Problem Description
Ppf alleges metal wear.
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.Udi: (b)(4).

• Brand Name: ASPHERE M SPEC 12/14 40 +8.5
• Common Device Name: ARTICULEZE HEAD (12/14 TAPER) : HIP METAL FEMORAL HEADS
• Manufacturer (Section D): DEPUY INTERNATIONAL LTD - 8010379; st. anthony's road; leeds IN LS11 8DT; UK LS11 8DT
• MDR Report Key: 7215054
• Report Number: 1818910-2018-51921
• Device Sequence Number: 164851
• Product Code: JDI
• UDI-Device Identifier: 10603295033011
• UDI-Public: 10603295033011
• Combination Product (Y/N): N
• Initial Reporter State: CO
• Initial Reporter Country: US
• PMA/510(K) Number: K082585
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2010
• Device Explanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: company representative,consum
• Initial Reporter Occupation: Health Professional
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date (Section B): 01/02/2018

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 Expiration Date: 10/31/2014
• Device Catalogue Number: 136507100
• Device Lot Number: 3016409
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 01/02/2018
• Supplement Date Received by Manufacturer: 08/01/2018; 08/23/2018; 02/05/2019; 02/15/2019
• Initial Report FDA Received Date: 01/24/2018
• Supplement Report FDA Received Date: 08/27/2018; 09/06/2018; 02/07/2019; 03/05/2019
• 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: Required Intervention
• Patient Age: 72 YR
• Patient Weight: 83