MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US ATTUNE CR FB INSRT SZ 3 10MM; KNEE TIBIAL BEARING/INSERT

Model Number	1516-20-310
Medical Device Problem Codes	Fracture (1260); Naturally Worn (2988)
Health Effect - Clinical Codes	No Consequences Or Impact To Patient (2199); No Information (3190)
Date of Event	08/15/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
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 patient was revised to address poly wear on the left medial side and some small pieces have broken off.It has also noted some substantial polyethylene failure.Tibial tray appeared to be well fixed on x- ray.In theatre the tray was removed with 4 or 5 strong taps of chisel and appeared ¿clean on its underside, cement mantle was fully fixed in patients tibia.
Additional Manufacturer Narrative
Product complaint: (b)(4).Investigation summary: review of the provided explant photographs confirms the reported event.Depuy considers the investigation closed at this time.Should additional information be received, the information will be reviewed and the investigation will be re-opened as necessary.(b)(4).Dhr reviewed, no deviations or nonconformance's were noted.Reassigned to sqe for ri review.Review of supplier certificate of compliance depuy synthes dhr reveals no inconsistencies concerning product delivered nor manufacturing operations at depuy if information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate. .
Additional Manufacturer Narrative
Depuy synthes is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on information which depuy synthes has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy synthes or its employees that the report constitutes an admission that the device, depuy synthes, or its employees caused or contributed to the potential event described in this report.Complaint # : (b)(4).Investigation summary: review of the provided explant photographs confirms the reported event.Depuy considers the investigation closed at this time.Should additional information be received, the information will be reviewed and the investigation will be re-opened as necessary.Device history lot: product code 151620310, lot number 309106.Device history review: dhr reviewed, no deviations or nonconformances were noted.Reassigned to sqe for ri review.Review of supplier certificate of compliance depuy synthes dhr reveals no inconsistencies concerning product delivered nor manufacturing operations at depuy.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 CR FB INSRT SZ 3 10MM
• Common Device Name: KNEE TIBIAL BEARING/INSERT
• Manufacturer (Section D): DEPUY ORTHOPAEDICS INC US; 700 orthopaedic drive; warsaw IN 46582
• MDR Report Key: 6864396
• Report Number: 1818910-2017-24577
• Device Sequence Number: 801068
• Product Code: JWH
• UDI-Device Identifier: 10603295045441
• UDI-Public: 10603295045441
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: K101433
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,health professional,o
• Initial Reporter Occupation: Health Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 08/15/2017

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?: No
• Operator of Device: Health Professional
• Device Model Number: 1516-20-310
• Device Catalogue Number: 151620310
• Device Lot Number: 309106
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 08/15/2017
• Supplement Date Received by Manufacturer: 06/27/2018; 01/24/2020
• Initial Report FDA Received Date: 09/14/2017
• Supplement Report FDA Received Date: 07/03/2018; 02/14/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 65 YR