MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS, INC. 1818910 ELITE IMPL TR HD 28MM +0; HIP INSTRUMENTS : FEMORAL TRIALS

Model Number	2522-28-002
Medical Device Problem Codes	Device-Device Incompatibility (2919); Material Deformation (2976); Scratched Material (3020)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	06/27/2018
Type of Reportable Event	Malfunction
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
Event: when the surgeon performed the stability test with the test head with anterior dislocation ; when he was attempting reduction, the head escaped the cone and was no longer found.After several manual search attempts, we chose to give up because of the risk of neurovascular 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.
Additional Manufacturer Narrative
Investigation summary: examination of the returned instrument found the alleged complaint unconfirmed but found a different failure upon inspection of the instrument.Depuy considers the investigation closed at this time.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
Product complaint #: (b)(4).Investigation summary : examination of the returned instrument found the alleged complaint unconfirmed but found a different failure upon inspection of the instrument.Depuy considers the investigation closed at this time.Should additional information be received, the information will be reviewed and the investigation will be re-opened as necessary.
Event or Problem Description
Examination of the returned instrument cannot confirm the complaint as instrument was returned, however, upon further visual analysis, the trial head appears to be heavy nicked/scratched.
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: examination of the returned instrument found the alleged complaint unconfirmed but found a different failure upon inspection of the instrument.Depuy considers the investigation closed at this time.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: ELITE IMPL TR HD 28MM +0
• Common Device Name: HIP INSTRUMENTS : FEMORAL TRIALS
• Manufacturer (Section D): DEPUY ORTHOPAEDICS, INC. 1818910 ; 700 orthopaedic drive; warsaw IN 46582 0988
• MDR Report Key: 7714188
• Report Number: 1818910-2018-65080
• Device Sequence Number: 10988857
• Product Code: LXH
• UDI-Device Identifier: 10603295128595
• UDI-Public: 10603295128595
• Combination Product (Y/N): N
• Initial Reporter Country: BR
• PMA/510(K) Number: NI
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date (Section B): 09/06/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 2522-28-002
• Device Catalogue Number: 252228002
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/14/2018
• Initial Date Received by Manufacturer: 06/28/2018
• Supplement Date Received by Manufacturer: 08/15/2018; 09/06/2018; 09/06/2018; 04/08/2020
• Initial Report FDA Received Date: 07/24/2018
• Supplement Report FDA Received Date: 08/20/2018; 09/21/2018; 10/03/2018; 05/05/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 75 YR