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 Problem Device Dislodged or Dislocated (2923)

Patient Problems Fall (1848); Unspecified Tissue Injury (4559)

Event Date 08/17/2022

Event Type  Injury  

Manufacturer Narrative

Product complaint # pc-(b)(4).

Event Description

Patient with a hinge srom knee fell and loosened the femoral component from the sleeve.The patient has no functioning quad or patella.Right.Old hinge femur and insert were removed and a new one was replaced.Doi: (b)(6) 2021.Dor: (b)(6) 2022.

Event Description

Additional information received indicated that there was no surgical delay reported.

Manufacturer Narrative

Product complaint # (b)(4).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 (nc search) was performed for the finished device 623411l, lot j91w19 and no non-conformances / manufacturing irregularities were identified.Updated the concomitant product unknown knee femoral adaptor to unknown knee femoral sleeve.

• 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
• Manufacturer (Section G): DEPUY RAYNHAM, A DIV. OF DEPUY ORTHO 1219655; 325 paramount drive; raynham MA 02767
• Manufacturer Contact: kate karberg ; 700 orthpaedic dr.; warsaw, IN 46581 ; 3035526892
• MDR Report Key: 15397609
• MDR Text Key: 299667218
• Report Number: 1818910-2022-17584
• Device Sequence Number: 1
• Product Code: KRO
• UDI-Device Identifier: 10603295179481
• UDI-Public: 10603295179481
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K896048
• 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: 09/10/2022

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: 62-3411L
• Device Catalogue Number: 623411L
• Device Lot Number: J91W19
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 08/17/2022
• Initial Date FDA Received: 09/10/2022
• Supplement Dates Manufacturer Received: 09/16/2022
• Supplement Dates FDA Received: 09/19/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/06/2020
• 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: LPS UNIV TIB HIN INS SM 26MM; UNKNOWN KNEE FEMORAL ADAPTOR; UNKNOWN KNEE FEMORAL SLEEVE
• Patient Outcome(s): Required Intervention
• Patient Age: 71 YR
• Patient Sex: Female