MAUDE Adverse Event Report: DEPUY IRELAND 9616671 ATTUNE PS FB INSRT SZ 6 10MM; ATTUNE IMPLANT : KNEE TIBIAL INSERT

Model Number 1516-40-610

Device Problems Adverse Event Without Identified Device or Use Problem (2993); Insufficient Information (3190)

Patient Problems Adhesion(s) (1695); Muscular Rigidity (1968); Pain (1994); Limited Mobility Of The Implanted Joint (2671); No Code Available (3191)

Event Date 06/25/2018

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

The patient was revised to address stiffness and pain.Doi: unknown; dor: (b)(6) 2018; right knee.

Manufacturer Narrative

Product complaint #
=
> pc-(b)(4).Investigation summary
=
> no device associated with this report was received for examination.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

Manufacturer Narrative

  udi: (b)(4).(b)(4)to capture medical device removal.

Event Description

Medical records alleges adhesion, medical device site joint movement impairment and extraskeletal ossification.

Manufacturer Narrative

Product complaint # (b)(4).Investigation summary : no device associated with this report was received for examination.Depuy synthes considers the investigation closed.Should additional information be received, the information will be reviewed and the investigation may be re-opened as necessary.H10 additional narrative: added: h6 patient code: no code available (3191) was used to capture surgical intervention.

• Brand Name: ATTUNE PS FB INSRT SZ 6 10MM
• Type of Device: ATTUNE IMPLANT : KNEE TIBIAL INSERT
• Manufacturer (Section D): DEPUY IRELAND 9616671; loughbeg ringaskiddy co.; cork ; EI
• MDR Report Key: 7702192
• MDR Text Key: 114415346
• Report Number: 1818910-2018-64757
• Device Sequence Number: 1
• Product Code: JWH
• UDI-Device Identifier: 10603295050100
• UDI-Public: 10603295050100
• Combination Product (y/n): N
• PMA/PMN Number: K111433
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,consum
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 06/25/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/19/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 07/31/2021
• Device Model Number: 1516-40-610
• Device Catalogue Number: 151640610
• Device Lot Number: C73222
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 07/24/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: ATTUNE FB TIB BASE SZ 5 CEM; COMPETITOR'S BONE CEMENT
• Patient Outcome(s): Required Intervention
• Patient Age: 57 YR
• Patient Weight: 107