MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US LPS UNIV TIB HIN INS XSM 12MM; LPS AND S-ROM : KNEE TIBIAL INSERT

Model Number 1987-27-112

Device Problem Device Dislodged or Dislocated (2923)

Patient Problem Joint Dislocation (2374)

Event Date 08/25/2022

Event Type  Injury  

Manufacturer Narrative

Product complaint # (b)(4).Depuy synthes is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on information which depuy synthes has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy synthes or its employees that the report constitutes an admission that the device, depuy synthes, 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 medwatch, a follow-up medwatch will be filed as appropriate.

Event Description

Patient was revised due to dislocation.Patient had prior left total femur replacement and had presented with a dislocated left knee.The poly was dislocated from the tibial construct.Surgeon removed the poly insert and replaced with a new one and he also removed a segment of the total femur construct.I do not know the size of the lps segment removed.There was no loosening experienced.Doi: unknown.Dor: (b)(6) 2022.Affected side: left knee.

Manufacturer Narrative

Product complaint # (b)(4).This medwatch report was initially submitted on (b)(6) 2022.This report is being resubmitted as this report failed submission as a result of the electronic gateway.Please reference fda ticket (b)(4) for additional details 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 a manufacturing record evaluation (mre), was not possible because the required lot code was not provided.

• Brand Name: LPS UNIV TIB HIN INS XSM 12MM
• 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 02767
• Manufacturer Contact: kate karberg ; 700 orthopaedic dr.; warsaw, IN 46581-0988 ; 3035526892
• MDR Report Key: 15417127
• MDR Text Key: 299843572
• Report Number: 1818910-2022-17861
• Device Sequence Number: 1
• Product Code: KRO
• UDI-Device Identifier: 10603295079392
• UDI-Public: 10603295079392
• 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
• Report Date: 09/22/2022

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?: Yes
• Device Operator: Health Professional
• Device Model Number: 1987-27-112
• Device Catalogue Number: 198727112
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 08/25/2022
• Initial Date FDA Received: 09/14/2022
• Supplement Dates Manufacturer Received: 09/22/2022
• Supplement Dates FDA Received: 12/02/2022
• 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: UNK KNEE SEGMENT
• Patient Outcome(s): Required Intervention
• Patient Age: 75 YR