MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US TRI-LOCK BPS STD NK SZ2/3; HIP INSTRUMENTS : FEMORAL TRIALS

Catalog Number	201205100
Medical Device Problem Codes	Material Discolored (1170); Scratched Material (3020)
Health Effect - Clinical Code	Not Applicable (3189)
Date of Event	01/14/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).Investigation summary: examination of the returned instrument could not confirm the complaint.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.Territory (b)(4) reports that they cannot read sizes on neck trial.Examination of the returned instrument could not confirm the complaint.The size is located on the top of the head of the neck trial and can easily read the size 2 x 3 std.There is some slight discoloration around the etching; however, the size is still readable.Visual analysis found a significant amount of scratching around the neck of the trial.The root cause is attributed to heavy usage.The complaint sample consisted of (1) 201205100 tri-lock bps std neck size 2/3, date code (b)(4).The date code indicates the instrument was manufactured in june of 2008 and is over 10-years old.A search of the complaint database found no prior reports for this product code for this type of allegation.The investigation could not verify or identify any product contribution to the reported event with the information provided.Based on the investigation, the need for corrective action is 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
There is some slight discoloration around the etching; however, the size is still readable.Visual analysis found a significant amount of scratching around the neck of the trial.

• Brand Name: TRI-LOCK BPS STD NK SZ2/3
• Common Device Name: HIP INSTRUMENTS : FEMORAL TRIALS
• Manufacturer (Section D): DEPUY ORTHOPAEDICS INC US; 700 orthopaedic drive; warsaw IN 46581 0988
• MDR Report Key: 8419948
• Report Number: 1818910-2019-87230
• Device Sequence Number: 11209102
• Product Code: LXH
• UDI-Device Identifier: 10603295082200
• UDI-Public: 10603295082200
• Combination Product (Y/N): N
• Initial Reporter State: OK
• 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: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 01/14/2019

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?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: 201205100
• Device Lot Number: PG0608
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/07/2019
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/12/2019
• Initial Report FDA Received Date: 03/14/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 51 YR