MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS, INC. 1818910 LPS UNIV TIB HIN INS XXSM 16MM; LPS AND S-ROM : KNEE TIBIAL INSERT

Catalog Number 198727016

Device Problems Fracture (1260); Fitting Problem (2183)

Patient Problems Fall (1848); Joint Dislocation (2374)

Event Date 09/27/2018

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

It was reported that lps insert was undersized according to surgeon and began to lever which lead to dislocation.Upon removal it was discovered the distal posterior was fractured on the poly.Doi: unknown; dor: (b)(6) 2018; right knee.

Manufacturer Narrative

(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, a follow-up medwatch will be filed as appropriate. .

• Brand Name: LPS UNIV TIB HIN INS XXSM 16MM
• Type of Device: LPS AND S-ROM : KNEE TIBIAL INSERT
• Manufacturer (Section D): DEPUY ORTHOPAEDICS, INC. 1818910 ; 700 orthopaedic drive; warsaw IN 46582 0988
• Manufacturer (Section G): DEPUY ORTHOPAEDICS, INC. 1818910 ; 700 orthopaedic drive; warsaw IN 46582
• Manufacturer Contact: chad gibson ; 700 orthopaedic drive; warsaw, IN 46582-0988 ; 5743725905
• MDR Report Key: 7977474
• MDR Text Key: 124082632
• Report Number: 1818910-2018-72836
• Device Sequence Number: 1
• Product Code: KRO
• UDI-Device Identifier: 10603295079354
• UDI-Public: 10603295079354
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K091453
• 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
• Report Date: 09/27/2018

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?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 198727016
• Device Lot Number: BFI1601
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 09/27/2018
• Initial Date FDA Received: 10/18/2018
• Supplement Dates Manufacturer Received: 10/19/2018; 11/02/2018
• Supplement Dates FDA Received: 10/22/2018; 11/02/2018
• 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: 48 YR