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

Catalog Number 198727012

Device Problem Device Dislodged or Dislocated (2923)

Patient Problems Joint Dislocation (2374); Not Applicable (3189); No Code Available (3191)

Event Date 04/01/2019

Event Type  Injury  

Manufacturer Narrative

(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

It was reported that the patient fell out of bed and had her knee underneath her when she fell causing deep flexion and dislocating her knee.The surgeon removed the lps poly insert xx-small 12mm and xx-small pin.He put in a 14mm lps xx-small poly insert and xx-small pin.No defect with the insert removed or any other implants.Surgeon stated the patient could have an infection and placed stimulan impregnated with antibiotics as a prophylactic.Left knee.

Manufacturer Narrative

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.Product complaint #
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> (b)(4).Investigation summary
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> the device associated with the reported event was not received at the investigation site for evaluation.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.If information is obtained that was not available for the initial medwatch, a follow-up medwatch, a follow-up medwatch will be filed as appropriate.

• Brand Name: LPS UNIV TIB HIN INS XXSM 12MM
• Type of Device: LPS AND S-ROM : KNEE TIBIAL INSERT
• Manufacturer (Section D): DEPUY ORTHOPAEDICS INC US; 700 orthopaedic drive; warsaw IN 46582 0988
• MDR Report Key: 8544327
• MDR Text Key: 142902931
• Report Number: 1818910-2019-91471
• Device Sequence Number: 1
• Product Code: KRO
• UDI-Device Identifier: 10603295079330
• UDI-Public: 10603295079330
• Combination Product (y/n): N
• PMA/PMN Number: K091453
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 04/01/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/24/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 198727012
• Device Lot Number: 621584
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 05/28/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention