MAUDE Adverse Event Report: STANMORE IMPLANTS WORLDWIDE SHORT TIBIAL BEARING MK4 - STD; PROSTHESIS, KNEE, FEMOROTIBIAL, CONSTRAINED, CEMENTED, METAL/POLYMER

Catalog Number SMMLTB02

Device Problems Device-Device Incompatibility (2919); Insufficient Information (3190)

Patient Problems Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 04/11/2022

Event Type  malfunction  

Event Description

The following was reported during a revision of the patient's left distal femoral replacement."the implant we¿re revising appears to be a mk 3 tibia.I have mk 4 implants in the room.The old bearing is ok, but leaving it in isn¿t standard of care." spoke to rep.Surgeon elected to keep the in situ bearing in place.Current treatment plan for this patient is to observe and assess - there is no current plan to revise this patient.

Manufacturer Narrative

Should additional information become available, it will be provided in a supplemental report upon completion of the investigation.Device not returned.

Manufacturer Narrative

Reported event: an event regarding assembly issue involving a jts, distal femoral replacement was reported.The event was confirmed by review of inspection records.Method & results: device evaluation and results: not performed as product was not returned clinician review: no medical records were received for review with a clinical consultant device history review: review of the product history records indicate devices were manufactured and accepted into final stock with no reported discrepancies.Complaint history review: there have been no other events for the lot referenced conclusion: the investigation concluded that the assembly issue was caused by shipping incorrect components.The device (b)(4) bushings were supplied with the intention to mate with the mk3 metal casing in-situ, (b)(4) however, the mk4 short tibial bearing was supplied.During surgery, the user disassembled the in-situ mk3 bearing and attempted to assemble the new mk4 bearing, however due to the discrepancy the parts did not assemble.The surgeon completed the surgery by re-assembling the old mk3 bearing.An nc was issued for mk4 bearing sent when mk3 bearing was required.Product surveillance will continue to monitor for trends.Corrective action/preventive action: an nc was opened to investigate the root cause of this event.

Event Description

The following was reported during a revision of the patient's left distal femoral replacement."the implant we¿re revising appears to be a mk 3 tibia.I have mk 4 implants in the room.The old bearing is ok, but leaving it in isn¿t standard of care." spoke to rep.Surgeon elected to keep the in situ bearing in place.Current treatment plan for this patient is to observe and assess - there is no current plan to revise this patient.

Manufacturer Narrative

Reported event: an event regarding assembly issue involving a jts, distal femoral replacement was reported.The event was confirmed by review of inspection records.Method & results: device evaluation and results: not performed as product was not returned.Clinician review: no medical records were received for review with a clinical consultant.Device history review: review of the product history records indicate devices were manufactured and accepted into final stock with no reported discrepancies.Complaint history review: there have been no other events for the lot referenced.Conclusion: the investigation concluded that the assembly issue was caused by shipping incorrect components.The device (pin 22939) bushings were supplied with the intention to mate with the mk3 metal casing in-situ, (pin 9010) however, the mk4 short tibial bearing was supplied.During surgery, the user disassembled the in-situ mk3 bearing and attempted to assemble the new mk4 bearing, however due to the discrepancy the parts did not assemble.The surgeon completed the surgery by re-assembling the old mk3 bearing.Also the mk4 tibial bearing was thrown away at the end of the case.An nc was issued for mk4 bearing sent when mk3 bearing was required.Product surveillance will continue to monitor for trends.Corrective action/preventive action: an nc was opened to investigate the root cause of this event.Pfa z-1778-2022 has been issued.

Event Description

The following was reported during a revision of the patient's left distal femoral replacement."the implant we¿re revising appears to be a mk 3 tibia.I have mk 4 implants in the room.The old bearing is ok, but leaving it in isn¿t standard of care." spoke to rep.Surgeon elected to keep the in situ bearing in place.Current treatment plan for this patient is to observe and assess - there is no current plan to revise this patient.

• Brand Name: SHORT TIBIAL BEARING MK4 - STD
• Type of Device: PROSTHESIS, KNEE, FEMOROTIBIAL, CONSTRAINED, CEMENTED, METAL/POLYMER
• Manufacturer (Section D): STANMORE IMPLANTS WORLDWIDE; 210 centennial avenue; centennial park, elstree; borehamwood WD6 3 SJ; UK WD6 3SJ
• Manufacturer (Section G): STANMORE IMPLANTS WORLDWIDE; 210 centennial avenue; centennial park, elstree; borehamwood WD6 3 SJ; UK WD6 3SJ
• Manufacturer Contact: diana rogers ; 210 centennial avenue; centennial park, elstree; borehamwood WD6 3-SJ ; UK WD6 3SJ ; 2082386500
• MDR Report Key: 14286642
• MDR Text Key: 290775242
• Report Number: 3004105610-2022-00065
• Device Sequence Number: 1
• Product Code: KRO
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K140898
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Physician
• Remedial Action: Recall
• Type of Report: Initial,Followup,Followup
• Report Date: 09/28/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/05/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: SMMLTB02
• Device Lot Number: B24694
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/06/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/28/2019
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Removal/Correction Number: Z-1778-2022
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 52 YR
• Patient Sex: Male
• Patient Weight: 73 KG