MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US SROM MILLER SHELL SZ 19; HIP INSTRUMENTS : INSERTION DEVICES

Catalog Number 257605019

Device Problems Material Discolored (1170); Naturally Worn (2988)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 01/01/2018

Event Type  malfunction  

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 Description

Excessive wear and lack of sharpness of some s-rom loaner set especially when soiled with blood.

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.

Manufacturer Narrative

(b)(4).Investigation summary: examination of the returned instrument confirmed the complaint.Depuy considers the investigation closed at this time.If information is obtained that was not available for the initial medwatch , a follow-up medwatch, a follow-up medwatch will be filed as appropriate.

• Brand Name: SROM MILLER SHELL SZ 19
• Type of Device: HIP INSTRUMENTS : INSERTION DEVICES
• Manufacturer (Section D): DEPUY ORTHOPAEDICS INC US; 700 orthopaedic drive; warsaw IN 46581 0988
• Manufacturer (Section G): DEPUY ORTHOPAEDICS, INC. 1818910 ; 700 orthopaedic drive; warsaw IN 46582 0988
• Manufacturer Contact: kara ditty-bovard ; 1210 ward avenue; west chester, IN 19380-0988 ; 6103142063
• MDR Report Key: 8196881
• MDR Text Key: 131481755
• Report Number: 1818910-2018-79127
• Device Sequence Number: 1
• Product Code: HWT
• UDI-Device Identifier: 10603295145530
• UDI-Public: 10603295145530
• Combination Product (y/n): N
• Reporter Country Code: CA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,other
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 11/28/2018

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
• Device Operator: Health Professional
• Device Catalogue Number: 257605019
• Device Lot Number: AG0408
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/18/2018
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 11/28/2018
• Initial Date FDA Received: 12/26/2018
• Supplement Dates Manufacturer Received: 12/04/2018; 01/14/2019
• Supplement Dates FDA Received: 01/01/2019; 01/15/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/15/2008
• Is the Device Single Use?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1