MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US UNKNOWN KNEE FEMORAL AUGMENT; UNK KNEE FEMORAL AUGMENT

Catalog Number UNK KNEE FEMORAL AUGMENT

Device Problems Device Dislodged or Dislocated (2923); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Foreign Body Reaction (1868); Pain (1994); No Code Available (3191)

Event Date 04/14/2020

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

The patient was revised to address pain, instability and loosening of the femoral adapter bolt.As soon as the surgeon reached the joint space, metalosis was evident by black tissue.The poly was removed.The tibial tray was determined to be well fixed, but the surgeon was able to both rotate and piston the femoral component.Upon closer examination, it became clearly evident that the adaptor bolt was no longer engaged tightly with the femoral adaptor.The femoral stem appeared to be well fixed in the femoral canal.Therefore, the surgeon felt that the best treatment option was to removed the distal femur just proximal to the cemented stem and replace the distal femur with an lps femoral component and the segments necessary to restore femoral length and the joint line.Doi: (b)(6) 2005.Dor: (b)(6) 2020.Right 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.H10 additional narrative: corrected: h6 (device code and closure codes).Product complaint#: (b)(4).Investigation summary: no device associated with this report was received for examination.A worldwide lot specific complaint database search, or device history record (dhr) review, was not possible because the required lot number was not provided.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.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: UNKNOWN KNEE FEMORAL AUGMENT
• Type of Device: UNK KNEE FEMORAL AUGMENT
• Manufacturer (Section D): DEPUY ORTHOPAEDICS INC US; 700 orthopaedic drive; warsaw IN 46581 0988
• MDR Report Key: 9996089
• MDR Text Key: 188874949
• Report Number: 1818910-2020-11272
• Device Sequence Number: 1
• Product Code: KXA
• 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
• Report Date: 04/14/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/24/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: UNK KNEE FEMORAL AUGMENT
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 05/05/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: UNKNOWN KNEE FEMORAL; UNKNOWN KNEE FEMORAL ADAPTOR; UNKNOWN KNEE FEMORAL ADAPTOR BOLT; UNKNOWN KNEE FEMORAL AUGMENT; UNKNOWN KNEE FEMORAL AUGMENT; UNKNOWN KNEE FEMORAL SLEEVE; UNKNOWN KNEE FEMORAL STEM; UNKNOWN KNEE TIBIAL INSERT; UNKNOWN KNEE TIBIAL TRAY; UNKNOWN KNEE FEMORAL; UNKNOWN KNEE FEMORAL ADAPTOR; UNKNOWN KNEE FEMORAL ADAPTOR BOLT; UNKNOWN KNEE FEMORAL AUGMENT; UNKNOWN KNEE FEMORAL AUGMENT; UNKNOWN KNEE FEMORAL SLEEVE; UNKNOWN KNEE FEMORAL STEM; UNKNOWN KNEE TIBIAL INSERT; UNKNOWN KNEE TIBIAL TRAY
• Patient Outcome(s): Required Intervention
• Patient Age: 79 YR
• Patient Weight: 58