MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US LPS UNIV TIB HIN INS XSM 14MM; LPS AND S-ROM : KNEE TIBIAL INSERT

Model Number 1987-27-114

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

Patient Problems Inflammation (1932); Pain (1994); Loss of Range of Motion (2032); Ambulation Difficulties (2544); Swelling/ Edema (4577)

Event Date 12/11/2020

Event Type  Injury  

Event Description

This pc was created to capture the event on (b)(6) 2020.Medical records note the patient had pain in right knee, effusion, inflammation.The patient had an ultrasound and an aspiration done, and is to continue physical therapy.Awareness date: (b)(6) 2021.Doi: (b)(6) 2019 (tibial tray), (b)(6) 2019 (tibial insert).(b)(6) 2020 (femoral component), doe: (b)(6) 2020.This complaint was linked to (b)(4).This was created to capture the event happened (b)(6) 2020 as stated on aei note a-(b)(4).

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.

Manufacturer Narrative

Product complaint # (b)(4).Investigation summary no device associated with this report was received for examination.A worldwide lot specific complaint database search, or manufacturing record evaluation, was not possible as the required lot number was not provided.The information received will be retained for trend analysis, post market surveillance, or other events within the quality system.Device history lot a manufacturing record evaluation (mre) was not possible because the required lot code was not provided.

Event Description

Update ad 19 apr 2022: in relation to aei note (b)(4) under (b)(4), this (b)(4) has been re-opened due to medical records received from (b)(4).As per review by the clinician, the patient continued to have chronic right knee pain, walking difficulty, reduced rom and swelling after revision.The patient received a right knee ultrasound with aspiration and corticosteroid injection combined with continued physical therapy, which was ineffective.Between (b)(6) 2020 and (b)(6) 2022, the patient¿s pain management physician-administered 7 ketamine infusions to treat his right knee chronic regional pain syndrome (crps).The patient also received a right knee genicular nerve radiofrequency ablation (rfa) on (b)(6) 2022.There were no allegations of product defects nor were there any revision surgeries performed.All procedures were administered to treat the patient¿s ongoing chronic pain, swelling, reduced rom, and walking difficulty and will be captured as one event on (b)(4).

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: a1, b5, b7, d4 (catalog, udi), d10 (concomitant med products), g4 (pma/ 510(k)), h6 (health effect - clinical code) if information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.

Manufacturer Narrative

Product complaint # (b)(4).Investigation summary: no device associated with this report was received for examination.A worldwide lot specific complaint database search, or manufacturing record evaluation, was not possible as the required lot number was not provided.The information received will be retained for trend analysis, post market surveillance, or other events within the quality system.Device history lot: a manufacturing record evaluation (mre) was not possible because the required lot code was not provided.

• Brand Name: LPS UNIV TIB HIN INS XSM 14MM
• 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 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: 13154342
• MDR Text Key: 288363182
• Report Number: 1818910-2022-00103
• Device Sequence Number: 1
• Product Code: KRO
• UDI-Device Identifier: 10603295079408
• UDI-Public: 10603295079408
• 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: Health Professional,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 01/04/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/04/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 1987-27-114
• Device Catalogue Number: 198727114
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/16/2023
• 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
• Treatment: 40 MM UNIVERSAL POROUS-COATED FEMORAL SLEEVE; 41 MM 3 PEG OVAL DOME PATELLA; 75 X 18 MM FLUTED STEM; LPS 14MM HINGED TIBIAL INSERT; MBT REVISION ROTATING PLATFORM TIBIAL TRAY SIZE 4; SROM NOILES RIGHT ROTATING HINGE MEDIUM
• Patient Outcome(s): Required Intervention
• Patient Age: 56 YR
• Patient Sex: Male
• Patient Weight: 125 KG