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 Problem Renal Failure (2041)

Event Date 03/28/2014

Event Type  Injury  

Manufacturer Narrative

Product complaint # (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

Doi (b)(6) 2014: the infection was cleared and an lps distal femur, segment component, sleeve adaptor, femoral sleeve, lps tibial hinge insert, universal stem, mbt tray, mbt sleeve, and universal stem (see additional information provided with part/lot) was implanted.A free latissimus dorsi flap with vein grafting to correct a left knee skin defect present before the revision was also performed.Postoperatively, the developed acute renal failure requiring increasing iv fluids.Doe: (b)(6) 2014.

Manufacturer Narrative

Product complaint # (b)(4).Investigation summary no device associated with this report was received for examination.The information received will be retained for potential series investigations if triggered by trend analysis, post market surveillance, or other events within the quality system.Depuy considers the investigation closed.Should additional information be received, the information will be reviewed and the investigation will 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: kate karberg ; 700 orthopaedic dr.; warsaw, IN 46581-0988 ; 3035526892
• MDR Report Key: 13535057
• MDR Text Key: 285618963
• Report Number: 1818910-2022-02837
• 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: 02/07/2022
• Initial Date FDA Received: 02/15/2022
• Supplement Dates Manufacturer Received: 04/20/2022
• Supplement Dates FDA Received: 04/20/2022
• 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: STRYKER CEMENT (61969001); STRYKER CEMENT (61971001); STRYKER CEMENT (61971001); STRYKER CEMENT (61971001); STRYKER CEMENT (61971001); STRYKER CEMENT (61971001)
• Patient Outcome(s): Required Intervention
• Patient Age: 65 YR
• Patient Weight: 123 KG