MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US 12/14 ARTICUL 44MM M SPEC+15.5; HIP FEMORAL HEAD

Catalog Number	136565000
Medical Device Problem Codes	Corroded (1131); Metal Shedding Debris (1804); Naturally Worn (2988); Appropriate Device Problem Term/Code Not Available (3191)
Health Effect - Clinical Codes	Foreign Body Reaction (1868); Irritation (1941); Pain (1994); Loss of Range of Motion (2032)
Date of Event	08/29/2016
Type of Reportable Event	Serious Injury
Additional Manufacturer 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
Jun 27, 2017: legal medical records received.Pfs alleges pain, lack of mobility and leg discrepancy that resulted to rotoscoliosis, and lower back pain.After review of the medical records for mdr reportability, it was stated that the patient was revised to address trunnionosis with metal debris.Patient was noted to have significantly elevate metal ions.Revision note stated that there was a significant scarring between iliotibial band and vastus lateralis, fluid from the hip, chronic granulomatous tissue noticed in the pericapsular tissue.It was also stated that there was a metal wear and damage to the superior half of the femoral taper consistent with galvanic and crevice corrosion and damage to the taper on the femoral head.Clinic notes indicate some edema around the left hip.There are no lab values provided for the reported elevated metal ions.This complaint was updated on: jul 10, 2017.
Additional Manufacturer Narrative
Additional narrative: 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.
Event or Problem Description
Ppf alleges metallosis and loosening of stem.
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).
Additional Manufacturer Narrative
Depuy synthes is submitting this report pursuant to the provision of 21 cfr, part 803.The report may be based on the 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).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: 12/14 ARTICUL 44MM M SPEC+15.5
• Common Device Name: HIP FEMORAL HEAD
• Manufacturer (Section D): DEPUY ORTHOPAEDICS INC US; 700 orthopaedic drive; warsaw IN 46581 0988
• MDR Report Key: 6739592
• Report Number: 1818910-2017-21674
• Device Sequence Number: 16351617
• Product Code: JDI
• UDI-Device Identifier: 10603295034193
• UDI-Public: 10603295034193
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K060031
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2011
• Device Explanted Year: 2016
• Reporter Type: Manufacturer
• Report Source: consumer,other
• Initial Reporter Occupation: Attorney
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 06/27/2017

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: 03/01/2015
• Device Catalogue Number: 136565000
• Device Lot Number: 3102422
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 06/27/2017
• Supplement Date Received by Manufacturer: 08/22/2017; 09/10/2019; 12/17/2019
• Initial Report FDA Received Date: 07/25/2017
• Supplement Report FDA Received Date: 08/22/2017; 09/17/2019; 01/15/2020
• 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: Hospitalization; Required Intervention
• Patient Age: 59 YR
• Patient Weight: 54