MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US PINN TRL LNR LIPPED 54ODX32ID; HIP INSTRUMENTS : ACETABULAR TRIALS

Catalog Number	221832254
Medical Device Problem Codes	Break (1069); Naturally Worn (2988); Scratched Material (3020)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	02/16/2018
Type of Reportable Event	Malfunction
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
Total hip replacement - daa - dr (b)(6), (b)(6) hospital.Dr (b)(6) was having difficulty in being able to see the markings on the trial liner due to being heavily scratched as well as being faded.The grub screw also fell out when removing the liner from the patient requiring the surgeon to get an additional instrument to find and retrieve the screw.Action taken: open the second set of trial liners which were available.No delay to procedure.No ae to patient.Male patient initials (b)(6).N.
Additional Manufacturer Narrative
(b)(4).The instrument associated with this report was not returned.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: PINN TRL LNR LIPPED 54ODX32ID
• Common Device Name: HIP INSTRUMENTS : ACETABULAR TRIALS
• Manufacturer (Section D): DEPUY ORTHOPAEDICS INC US; 700 orthopaedic drive; warsaw IN 46582 0988
• MDR Report Key: 7331338
• Report Number: 1818910-2018-54887
• Device Sequence Number: 119479
• Product Code: LXH
• UDI-Device Identifier: 10603295100935
• UDI-Public: 10603295100935
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 02/16/2018

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 Catalogue Number: 221832254
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 02/16/2018
• Supplement Date Received by Manufacturer: 12/11/2018
• Initial Report FDA Received Date: 03/12/2018
• Supplement Report FDA Received Date: 12/12/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1