MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US LPS UNIV TIB HIN INS XXSM 18MM LPS AND S-ROM : KNEE TIBIAL INSERT

Model Number 1987-27-018

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Fall (1848); Unspecified Infection (1930); Pain (1994); Scar Tissue (2060); Ambulation Difficulties (2544)

Event Date 06/02/2017

Event Type  Injury  

Event Description

The patient was revised due to aseptic loosening. Doi: unknown, dor: (b)(6) 2021, unknown knee side.

Manufacturer Narrative

(b)(4). The devices are reported under (b)(4) as the patient experienced adverse events on different days with the same devices. If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

• Brand Name: LPS UNIV TIB HIN INS XXSM 18MM
• Type of Device: LPS AND S-ROM : KNEE TIBIAL INSERT
• Manufacturer (Section D): DEPUY ORTHOPAEDICS INC US; 700 orthopaedic drive; warsaw IN 46581 0988
• Manufacturer (Section G): DEPUY RAYNHAM, A DIV. OF DEPUY ORTHO 1219655; 325 paramount drive; raynham MA 02767
• Manufacturer Contact: kara ditty-bovard ; 700 orthopaedic dr.; warsaw, IN 46581-0988 ; 6107428552
• MDR Report Key: 13534869
• Report Number: 1818910-2022-02830
• Device Sequence Number: 1
• Product Code: KRO
• UDI-Device Identifier: 10603295079361
• UDI-Public: 10603295079361
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: K091453
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Study,Health Professional
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 02/15/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/15/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No

Device Operator

• Device Model Number: 1987-27-018
• Device Catalogue Number: 198727018
• Device Lot Number: 360612
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/04/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/28/2013
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Age: 65 YR
• Patient Sex: No Answer Provided
• Patient Weight: 123 KG
• Patient Treatment(s): ALLOSOURCE MISCELLANEOUS TISSUE 104682109; LPS DISTAL FEM COMP XXSM LT; LPS FEM TO SLEEVE ADAPTER +5; LPS SEGMENTAL COMPONENT 45MM; LPS UNIV TIB HIN INS XXSM 18MM; MBT REV TIB TRAY SIZE 2 25MM; MBT TRAY SLEEVE POR M/L 61MM; STRYKER CEMENT; STRYKER CEMENT 61971001; STRYKER CEMENT 61971001; STRYKER CEMENT 61971001; STRYKER CEMENT 61971001; STRYKER CEMENT 61971001; UNIVERSAL FEM SLV FUL POR 34MM; UNIVERSAL STEM 75X16MM FLUTED; UNIVERSAL STEM 75X20MM FLUTED
• Patient Outcome(s): Required Intervention