MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US SROM NRHFEM W/PIN SM LFT 66X62; LPS AND S-ROM : KNEE FEMORAL

Model Number 62-3411L

Device Problems Loss of or Failure to Bond (1068); Fracture (1260); Loss of Osseointegration (2408)

Patient Problems Inadequate Osseointegration (2646); No Code Available (3191); Insufficient Information (4580)

Event Date 10/21/2020

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 due to loosening of the srom femur at the bone to implant interface.Post of srom hinge femoral component broke in-situ and part of post was stuck in universal femoral sleeve.Surgeon believes it broke under pressure.Surgeon had to remove femoral sleeve and press fit stem.Femur was revised.Doi: (b)(6) 2017.Dor: (b)(6) 2020; left knee.

Manufacturer Narrative

Product complaint # (b)(4).Investigation summary : no device associated with this report was received for examination.Depuy synthes considers the investigation closed.Should additional information be received, the information will be reviewed and the investigation may be re-opened as necessary.Device history lot : dhr reviewed no deviations or nonconformance's were noted.H6 clinical code: removed the code for inadequate osteointegration and replaced with insufficient information (e2401).H6 medical device problem code: removed code for osseointegration and replaced with loss of or failure to bond (a040102).

• Brand Name: SROM NRHFEM W/PIN SM LFT 66X62
• Type of Device: LPS AND S-ROM : KNEE FEMORAL
• Manufacturer (Section D): DEPUY ORTHOPAEDICS INC US; 700 orthopaedic drive; warsaw IN 46581 0988
• MDR Report Key: 10792900
• MDR Text Key: 214809401
• Report Number: 1818910-2020-24032
• Device Sequence Number: 1
• Product Code: KRO
• UDI-Device Identifier: 10603295179481
• UDI-Public: 10603295179481
• Combination Product (y/n): N
• PMA/PMN Number: K896048
• 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: 10/21/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/05/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 62-3411L
• Device Catalogue Number: 623411L
• Device Lot Number: C88168
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 12/14/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: LPS UNIV TIB HIN INS SM 12MM; UNIVERSAL FEM SLV FUL POR 46MM; UNIVERSAL STEM 150X20MM FLUTED; LPS UNIV TIB HIN INS SM 12MM; UNIVERSAL FEM SLV FUL POR 46MM; UNIVERSAL STEM 150X20MM FLUTED
• Patient Outcome(s): Required Intervention
• Patient Age: 71 YR