MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US ATTUNE RP PS ARTIC SURF SZ5; ATTUNE INSTRUMENTS : TIBIAL TRIALS

Catalog Number 254500545

Device Problem Entrapment of Device (1212)

Patient Problems Discomfort (2330); No Code Available (3191)

Event Date 10/31/2019

Event Type  Injury  

Manufacturer Narrative

(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 patient showed up for 3 month follow up, having some discomfort in her surgically replaced left knee.X-rays showed what appears to be the spring off of the trial insert still in the patient, that must have been dislodged during surgery.No one was aware the spring had come off.Patient is being scheduled for a revision surgery to remove the spring and replace the poly insert.Doi: (b)(6) 2019; dor: being scheduled left knee.

Manufacturer Narrative

Product complaint # (b)(4).

Manufacturer Narrative

Product complaint # (b)(4).Investigation summary
=
> the device associated with the reported event was not returned for examination.The investigation could not draw any conclusions about the reported event based on the limited information provided.Depuy synthes considers the investigation closed at this time.Should additional information be received, the information will be reviewed and the investigation may be re-opened as necessary.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: ATTUNE RP PS ARTIC SURF SZ5
• Type of Device: ATTUNE INSTRUMENTS : TIBIAL TRIALS
• Manufacturer (Section D): DEPUY ORTHOPAEDICS INC US; 700 orthopaedic drive; warsaw IN 46581 0988
• Manufacturer (Section G): DEPUY ORTHOPAEDICS, INC. 1818910; 700 orthopaedic dr.; warsaw IN 46581 0988
• Manufacturer Contact: kara ditty-bovard ; 1210 ward avenue; west chester, PA 19380-0988 ; 6103142063
• MDR Report Key: 9376239
• MDR Text Key: 168067848
• Report Number: 1818910-2019-118060
• Device Sequence Number: 1
• Product Code: JWH
• UDI-Device Identifier: 10603295132851
• UDI-Public: 10603295132851
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K140881
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 10/31/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 254500545
• Device Lot Number: MVMCJH300
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/31/2019
• Initial Date FDA Received: 11/26/2019
• Supplement Dates Manufacturer Received: 10/31/2019; 12/27/2019
• Supplement Dates FDA Received: 11/28/2019; 12/27/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/23/2014
• 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 Outcome(s): Required Intervention