MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US LPS SEGMENTAL COMPONENT 45MM; LPS AND S-ROM : KNEE ACCESSORY

Model Number 1987-07-045

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  

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.

Event Description

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

Manufacturer Narrative

Product complaint # (b)(4).Investigation summary: the device was not returned.All available x-rays were reviewed, and no evidence of implant fracture, disassociation, or anything indicative of a device nonconformance was found.Depuy synthes considers the investigation closed at this time.Should additional information be received, the information will be reviewed, and the investigation may be re-opened as necessary.Device history lot: the product investigation found no evidence suspecting an error in the manufacturing or material that would be a contributing factor in the reported allegation(s).A manufacturing records evaluation (mre) was not performed.

• Brand Name: LPS SEGMENTAL COMPONENT 45MM
• Type of Device: LPS AND S-ROM : KNEE ACCESSORY
• Manufacturer (Section D): DEPUY ORTHOPAEDICS INC US; 700 orthopaedic drive; warsaw IN 46581 0988
• Manufacturer (Section G): DEPUY ORTHOPAEDICS, INC. 1818910; 700 orthopaedic dr.; warsaw IN 46581 0988
• Manufacturer Contact: kara ditty-bovard ; 700 orthopaedic dr.; warsaw, IN 46581-0988 ; 6107428552
• MDR Report Key: 13534867
• MDR Text Key: 285617489
• Report Number: 1818910-2022-02827
• Device Sequence Number: 1
• Product Code: JDI
• UDI-Device Identifier: 10603295078555
• UDI-Public: 10603295078555
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: K033959
• 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

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 1987-07-045
• Device Catalogue Number: 198707045
• Device Lot Number: 460830
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/01/2022
• Initial Date FDA Received: 02/15/2022
• Supplement Dates Manufacturer Received: 04/04/2022
• Supplement Dates FDA Received: 04/04/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/12/2013
• 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
• Treatment: 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
• Patient Age: 65 YR
• Patient Weight: 123 KG