MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS, INC. US 1818910 S/C & MOD CATH TRL 53/28; HIP INSTRUMENTS : ACETABULAR TRIALS

Catalog Number	205553000
Medical Device Problem Code	Scratched Material (3020)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	01/23/2018
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
The cathcart head trial has deep scratches on it causing a sterilization concern.
Additional Manufacturer Narrative
Product complaint # : (b)(4).No device associated with this report was received for examination, however, following investigation by depuy australia it was concluded that the complaint was due to wear and tear.A worldwide complaint database search found no other reported incident(s) against the provided product/lot combination(s) since release for distribution.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 53/28
• Common Device Name: HIP INSTRUMENTS : ACETABULAR TRIALS
• Manufacturer (Section D): DEPUY ORTHOPAEDICS, INC. US 1818910; 700 orthopaedic drive; warsaw IN 46582 0988
• MDR Report Key: 8181657
• Report Number: 1818910-2018-78763
• Device Sequence Number: 1915504
• Product Code: LXH
• UDI-Device Identifier: 10603295084709
• UDI-Public: 10603295084709
• 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: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 11/26/2018

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: 205553000
• Device Lot Number: AF0408
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 11/26/2018
• Supplement Date Received by Manufacturer: 01/14/2019
• Initial Report FDA Received Date: 12/19/2018
• Supplement Report FDA Received Date: 01/15/2019
• Patient Sequence Number: 1