MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US PRESERVATION UNI FEM CEM SZ2; EARLY INTERVENTION : KNEE FEMORAL

Catalog Number 149801002

Device Problems Loss of or Failure to Bond (1068); Loosening of Implant Not Related to Bone-Ingrowth (4002)

Patient Problems Pain (1994); Not Applicable (3189); No Code Available (3191)

Event Date 10/16/2019

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

Patient was revised for pain and femoral loosening.Extracted the femoral uni sz 2 component and tibial alpoly sz 2, 7mm insert.Implanted an attune femur and rp s+ tibial tray with rp stabilize insert and patella.This was on the patient's left knee.Was other medical intervention (e.G.X-rays, additional procedures, prescriptions, otc, revision) required: yes, if yes, describe: revised patient for pain and femoral loosening.

Event Description

It was reported that there was no delay in surgery.Not applicable code that is used to capture surgery prolonged was removed.

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.

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 # (b)(4).The device associated with this report was not received for examination.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 : null.Device history batch : null.Device history review : null.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: PRESERVATION UNI FEM CEM SZ2
• Type of Device: EARLY INTERVENTION : KNEE FEMORAL
• Manufacturer (Section D): DEPUY ORTHOPAEDICS INC US; 700 orthopaedic drive; warsaw IN 46581 0988
• MDR Report Key: 9286363
• MDR Text Key: 165398291
• Report Number: 1818910-2019-114505
• Device Sequence Number: 1
• Product Code: HRY
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup,Followup
• Report Date: 10/11/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/06/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 149801002
• Device Lot Number: 1976614
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 12/03/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: PRSVN ALLPOLY TIB LMRL S2 7MM
• Patient Outcome(s): Required Intervention
• Patient Age: 71 YR
• Patient Weight: 81