MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US LPS UNIV TIB HIN INS XXSM 16MM; LPS AND S-ROM : KNEE TIBIAL INSERT

Catalog Number 198727016

Device Problem Device Dislodged or Dislocated (2923)

Patient Problems Pain (1994); Loss of Range of Motion (2032); Discomfort (2330); Joint Laxity (4526); Insufficient Information (4580)

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

Patient was revised due to dislocating hinge.Only poly and pin was revised.Doi: unknown.Dor: (b)(6) 2021.Unknown knee side.

Manufacturer Narrative

Product complaint # (b)(4).Investigation summary: no device associated with this report was received for examination.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 (mrae) was not performed.

Event Description

Medical records received.The patient had a left knee placed in 2007 (unknown manufacturer).The patient underwent an i&d and poly exchange in 2016.The patient then underwent a stage 1 and stage 2 revision in 2016 (still unknown manufacturer).The patient underwent another stage 1 in (b)(6) 2018 and stage 2 on (b)(6) 2018 when depuy implants were placed with competitor cement.(b)(6) 2019: the patient presented with pain/discomfort and decreased rom.The patient was found to have a posterior hinge dislocation.(b)(6) 2019: the patient underwent a revision and the insert was exchanged.During the revision, the implants were found to be stable and the patient was noted to have a patella subluxation.At this time it's unknown if the patella had been resurfaced.Doi - (b)(6) 2018.Dor - (b)(6) 2019.Left knee.

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.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.

• Brand Name: LPS UNIV TIB HIN INS XXSM 16MM
• 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 46581 0988
• Manufacturer Contact: kara ditty-bovard ; 700 orthopaedic dr.; warsaw, IN 46581-0988 ; 6107428552
• MDR Report Key: 13265902
• MDR Text Key: 283946451
• Report Number: 1818910-2022-00941
• 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,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 01/17/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/17/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 198727016
• Device Lot Number: 575270
• 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: 09/24/2014
• 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: COMPETITOR CEMENT; LPS CEMENTED STEM 13X125MM STR; LPS DISTAL FEM COMP XXSM LT; LPS UNIV TIB HIN INS XXSM 16MM; LPS XX-SM HINGE PIN; MBT REV TIB TRAY SIZE 2 15MM; SIG TIB CEM STM 13X60 2/2.5/3; UNK KNEE TIBIAL INSERT LPS
• Patient Outcome(s): Required Intervention
• Patient Age: 66 YR
• Patient Sex: Male
• Patient Weight: 125 KG