MAUDE Adverse Event Report: DEPUY ORTHOPAEDIC INC, 1818910 UNKNOWN OTHER PRODUCTS

Catalog Number UNK KNEE INSTRUMENT

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 07/02/2018

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

It was reported that the size 3 ps femur box screw is stripped and stuck inside femur trial.

Manufacturer Narrative

(b)(4).Investigation summary: the device associated with this report was not returned for evaluation.The investigation could not draw any conclusions about the reported event without the device to examine.Depuy considers the investigation closed.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: UNKNOWN OTHER PRODUCTS
• Type of Device: OTHER PRODUCTS
• Manufacturer (Section D): DEPUY ORTHOPAEDIC INC, 1818910; 700 orthopaedic drive; warsaw IN 46582 0988
• Manufacturer (Section G): DEPUY ORTHOPAEDIC INC, 1818910; 700 orthopaedic drive; warsaw IN 46582
• Manufacturer Contact: kara ditty-bovard ; 700 orthopaedic drive; warsaw, IN 46582-0988 ; 6103142063
• MDR Report Key: 7718373
• MDR Text Key: 115375039
• Report Number: 1818910-2018-65178
• Device Sequence Number: 1
• Product Code: HWC
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 07/02/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: UNK KNEE INSTRUMENT
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 07/02/2018
• Initial Date FDA Received: 07/25/2018
• Supplement Dates Manufacturer Received: 11/26/2018
• Supplement Dates FDA Received: 11/27/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 66 YR