MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US LPS UNIV TIB HIN INS XSM 23MM; LPS AND S-ROM : KNEE TIBIAL INSERT

Catalog Number 198727123

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

Patient Problems Wound Dehiscence (1154); Hemorrhage/Bleeding (1888); Unspecified Infection (1930); Scar Tissue (2060); Impaired Healing (2378); Fluid Discharge (2686)

Event Date 12/15/2021

Event Type  Injury  

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

Repeat stage 2 infection.

Manufacturer Narrative

Product complaint # (b)(4).Investigation summary : an analysis of the product could not be performed since a physical sample was not received for evaluation.As part of our company quality system process, all devices are manufactured, inspected, and distributed to approved specifications.Additional complaint information monitoring for potential safety signals will be conducted through complaint trending as part of the post-market surveillance.However, if the product is received at a later date, the investigation will be updated as applicable.

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.

Event Description

Operative notes on (b)(6) 2014 indicate the patient received a right total knee stage 2 re-implantation of depuy lps post static spacer for treatment of infection removal.Extensive scarring was encountered and removed.Intraoperatively, significant bleeding at the posterolateral side was encountered originating from the popliteal artery and this bleeding was stopped by packing and the use of vascular clips, total blood loss was 500 ml.Office notes on (b)(6) 2014 indicate the patient is experiencing delayed wound healing with bloody serious fluid draining.One-week later knee had become obviously infected.Revision operative notes on (b)(6) 2014 indicate the patient received a right total knee revision due to infection.Upon entering the joint large amounts of hemorrhagic fluid was removed.The inner arthrotomy was also dehisced and utilized to fully enter the joint.A full explant was performed, and competitor implants and cement were implanted as an antibiotic spacer for the treatment of known infection.The surgery was completed without indication of complication by the surgeon.Operative side: right.

Manufacturer Narrative

Product complaint#: (b)(4).This report is being submitted pursuant to the provisions of 21 cfr, part 803.This report may be based on information which has not been investigated or verified prior to the required reporting date.This report does not reflect a conclusion by depuy synthes joint reconstruction, or its employees that the report constitutes an admission that the product, depuy synthes joint reconstruction, or its employees caused or contributed to the potential event described in this report.H10 additional narrative: added: a2 (age) and h6 (clinical codes).If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.Corrected: d4 (catalog) and h6 (impact code).

• Brand Name: LPS UNIV TIB HIN INS XSM 23MM
• 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): JTE RAYNHAM MFG SITE; 325 paramount drive; raynham MA 02767 0988
• Manufacturer Contact: kara ditty-bovard ; 700 orthopaedic dr.; warsaw, IN 46581-0988 ; 6107428552
• MDR Report Key: 13385672
• MDR Text Key: 284632950
• Report Number: 1818910-2022-01857
• Device Sequence Number: 1
• Product Code: KRO
• 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,Followup,Followup
• Report Date: 01/28/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/28/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 198727123
• Device Lot Number: 400394
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/31/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/11/2013
• 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: LPS DISTAL FEM COMP XSM RT.; LPS FEM TO SLEEVE ADAPTER +10.; LPS UNIV TIB HIN INS XSM 23MM.; MBT REV TIB TRAY SIZE 2 15MM.; MBT TRAY SLEEVE POR M/L 53MM.; STRYKER CEMENT 61971001.; STRYKER CEMENT 61971001.; UNIVERSAL FEM SLV FUL POR 40MM.; UNIVERSAL STEM 75X18MM FLUTED.; UNIVERSAL STEM 75X20MM FLUTED.
• Patient Outcome(s): Required Intervention
• Patient Age: 64 YR
• Patient Weight: 154 KG