MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC 1818910 S/C & MOD CATH TRL 39/22.225; HIP INSTRUMENTS : ACETABULAR TRIALS

Catalog Number	205739000
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	08/17/2018
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
It was reported that the trial cup (lot# was unknown) was broken when the surgeon performed the reduction with reducted the trial cup during bha surgery on (b)(6) 2018.The surgeon removed the all broken fragment from the patient¿s body, and confirmed that there was no broken fragment was remained in the patient¿s body under x-ray.Thus, the surgery was completed without any other problem.There was less than 30 min.Surgical delay and there was no adverse consequence to the patient.No further information was provided by the hospital.
Additional Manufacturer Narrative
Product complaint # (b)(4).Investigation summary: no device associated with this report was received for examination.Depuy synthes 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: S/C & MOD CATH TRL 39/22.225
• Common Device Name: HIP INSTRUMENTS : ACETABULAR TRIALS
• Manufacturer (Section D): DEPUY ORTHOPAEDICS INC 1818910; 700 orthopaedic drive; warsaw IN 46582 0988
• MDR Report Key: 7871255
• Report Number: 1818910-2018-69201
• Device Sequence Number: 1911318
• Product Code: LXH
• UDI-Device Identifier: 10603295084815
• UDI-Public: 10603295084815
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• 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
• Report Date (Section B): 08/17/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: 205739000
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/17/2018
• Supplement Date Received by Manufacturer: 10/17/2018
• Initial Report FDA Received Date: 09/12/2018
• Supplement Report FDA Received Date: 10/18/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1