MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US 11/13 TAPER HEAD TRIAL 28MM +3; HIP INSTRUMENTS : FEMORAL TRIALS

Catalog Number	875960
Medical Device Problem Code	Scratched Material (3020)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	07/14/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Product complaint # (b)(4).Investigation summary: the device associated with this report was not returned, thus the reported event could not be confirmed.The investigation could not verify or identify any product contribution to the reported event with the information provided.Depuy synthes considers the investigation closed at this time.Should additional information be received, the information will be reviewed and the investigation may be re-opened as necessary.Territory 239 reports the head ball trial 28+3mm has scratched.No surgical delay.The device associated with this report was not returned; follow up information states the trial was discarded.A search of the complaint database found prior reports for scratches that were attributed to misuse and/or heavy usage.The lot number that determines the age of the trial was not provided.The investigation could not verify or identify any product contribution to the reported event with the information provided.Based on the inability to identify root cause, the need for corrective action was not indicated.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
It was reported that the thread on the trial srom neck was stripped and they won't tighten to the stem trial.The head ball trial 28+3mm has scratched.No surgical delay.

• Brand Name: 11/13 TAPER HEAD TRIAL 28MM +3
• Common Device Name: HIP INSTRUMENTS : FEMORAL TRIALS
• Manufacturer (Section D): DEPUY ORTHOPAEDICS INC US; 700 orthopaedic drive; warsaw IN 46581 0988
• MDR Report Key: 9010268
• Report Number: 1818910-2019-104191
• Device Sequence Number: 2529421
• Product Code: LXH
• UDI-Device Identifier: 10603295218876
• UDI-Public: 10603295218876
• Combination Product (Y/N): N
• Initial Reporter State: NC
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 09/09/2019

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?: No
• Operator of Device: Health Professional
• Device Catalogue Number: 875960
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 09/09/2019
• Initial Report FDA Received Date: 09/12/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 79 YR