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

Device Problems Material Disintegration (1177); Naturally Worn (2988); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Host-Tissue Reaction (1297); Pain (1994); Not Applicable (3189)

Event Date 07/25/2018

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 pain.Worn out hinge bearing assembly.Doi: (b)(6) 2006.Dor: (b)(6) 2018; right knee.

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

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. .

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.

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.

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
• Type of Device: LPS AND S-ROM : KNEE TIBIAL INSERT
• Manufacturer (Section D): DEPUY ORTHOPAEDICS INC US; 700 orthopaedic drive; warsaw IN 46582 0988
• Manufacturer (Section G): DEPUY RAYNHAM ¿ 1219655 ; 325 paramount drive; raynham MA 02767
• Manufacturer Contact: kara ditty-bovard ; 1210 ward avenue; west chester, IN 19380-0988 ; 6103142063
• MDR Report Key: 7798358
• MDR Text Key: 117628674
• Report Number: 1818910-2018-67166
• Device Sequence Number: 1
• Product Code: KRO
• UDI-Device Identifier: 10603295178927
• UDI-Public: 10603295178927
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K011810
• 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,Followup,Followup,Followup
• Report Date: 07/25/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/20/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 621602
• Device Lot Number: BFA01VY0000
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/27/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 28 YR
• Patient Weight: 256