MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US SROM NRH TIB PLAT ASSY XS 16MM; LPS AND S-ROM : KNEE TIBIAL INSERT

Catalog Number	621602
Medical Device Problem Codes	Material Disintegration (1177); Naturally Worn (2988); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Host-Tissue Reaction (1297); Pain (1994); Not Applicable (3189)
Date of Event	07/25/2018
Type of Reportable Event	Serious Injury
Additional 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 or Problem Description
The patient was revised to address pain.Worn out hinge bearing assembly.Doi: (b)(6) 2006.Dor: (b)(6) 2018; right knee.
Additional 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 or Problem Description
The distal femur was articulating with parts of the hinge bearing assembly so scratching of that component was present and the hinge poly bearing was grossly worn out, and metal post in that hinge bearing was disarticulated from the actual hinge poly.Metallosis present in the joint. .
Additional 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.
Additional 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.
Additional Manufacturer Narrative
(b)(4).Investigation summary: the implant associated with this report was not returned.Depuy considers the investigation closed at this time.If information is obtained that was not available for the initial medwatch , a follow-up medwatch, will be filed as appropriate.

• Brand Name: SROM NRH TIB PLAT ASSY XS 16MM
• Common Device Name: LPS AND S-ROM : KNEE TIBIAL INSERT
• Manufacturer (Section D): DEPUY ORTHOPAEDICS INC US; 700 orthopaedic drive; warsaw IN 46582 0988
• MDR Report Key: 7798358
• Report Number: 1818910-2018-67166
• Device Sequence Number: 16640634
• Product Code: KRO
• UDI-Device Identifier: 10603295178927
• UDI-Public: 10603295178927
• Combination Product (Y/N): N
• Initial Reporter State: OK
• Initial Reporter Country: US
• PMA/510(K) Number: K011810
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2006
• Device Explanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date (Section B): 07/25/2018

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 Catalogue Number: 621602
• Device Lot Number: BFA01VY0000
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 07/25/2018
• Supplement Date Received by Manufacturer: 09/04/2018; 10/02/2018; 10/02/2018; 11/27/2018
• Initial Report FDA Received Date: 08/20/2018
• Supplement Report FDA Received Date: 09/18/2018; 10/16/2018; 10/16/2018; 11/29/2018
• 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: 28 YR
• Patient Weight: 256