MAUDE Adverse Event Report: STANMORE IMPLANTS WORLDWIDE DISTAL FEMUR - HINGE; PROSTHESIS, KNEE, FEMOROTIBIAL, CONSTRAINED, CEMENTED, METAL/POLYMER

Catalog Number UNK_STM

Device Problems Unstable (1667); Naturally Worn (2988)

Patient Problem Joint Laxity (4526)

Event Date 04/20/2022

Event Type  Injury  

Manufacturer Narrative

It was noted that the device is not available for evaluation.Should additional information become available, it will be provided in a supplemental report upon completion of the investigation review of the device history records indicate devices were manufactured and accepted into final stock with no relevant reported discrepancies.There have been no other similar events for the lot referenced.Device not returned.

Event Description

Stryker rep reported that "a patient with a stanmore custom implant distal 1/3 femoral and proximal ½ tibia replacement needs revising due to instability of the hinge secondary to worn bushings".

Event Description

Stryker rep reported that "a patient with a stanmore custom implant distal 1/3 femoral and proximal ½ tibia replacement needs revising due to instability of the hinge secondary to worn bushings".

Manufacturer Narrative

Reported event: an event regarding rebushing involving a patient specific distal femur was reported.The event was confirmed by x-ray review.Method & results: device evaluation and results: not performed as product was not returned.Clinician review: the implant in situ was for a proximal tibial and distal femoral replacement which was inserted on (b)(6) 1998 and rebushing in (b)(6) 2018.The surgeon reported instability of the hinge secondary to worn bushings.The x-ray images provided show uneven gap between the hinge and tibial component, indicating wear of the uhmwpe tibial bearing.The bushing wear cannot be clearly observed from the image but considering the duration of the component in situ it can be expected.Therefore, the radiographic review can confirm the clinical report and reason for revision.Product history review: review of the product history records indicate the device was 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 exact cause of the event could not be determined because insufficient information was provided.Additional information including operative reports, pathology reports, progress notes, return of the device are needed to fully investigate the event.If further information becomes available or the product is returned, this investigation will be re-opened.

• Brand Name: DISTAL FEMUR - HINGE
• 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: 14366367
• MDR Text Key: 291476671
• Report Number: 3004105610-2022-00075
• Device Sequence Number: 1
• Product Code: KRO
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: K140898
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 07/22/2022

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?: No
• Device Operator: Health Professional
• Device Expiration Date: 02/28/1999
• Device Catalogue Number: UNK_STM
• Device Lot Number: PIN 5821
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 04/20/2022
• Initial Date FDA Received: 05/11/2022
• Supplement Dates Manufacturer Received: 07/18/2022
• Supplement Dates FDA Received: 07/22/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/27/1998
• 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
• Patient Outcome(s): Required Intervention; Hospitalization
• Patient Age: 47 YR
• Patient Sex: Female