MAUDE Adverse Event Report: STANMORE IMPLANTS WORLDWIDE TIBIAL ROTATING COMPONENT; PROSTHESIS, KNEE, FEMOROTIBIAL, CONSTRAINED, CEMENTED, METAL/POLYMER

Catalog Number UNK_STM

Device Problem Packaging Problem (3007)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 03/16/2022

Event Type  malfunction  

Event Description

Stryker rep reported there were holes in the packaging of custom made components: "there was a packaging issue with pin 22902, operation date 16th march.There was a hole in the outer packaging of the rotating component that was noticed before the surgery started.This didn't compromise the operation as they had a mets component on the shelf.There was also a hole in both outer and inner wrapping of the custom proximal tibia component.This wasn't noticed until the implant was opened.The surgeon spoke to colleagues and followed advice to clean the custom tibia and implant into the patient.".

Manufacturer Narrative

The reported device is similar to a device approved for compassionate use in the united states.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.

Event Description

Stryker rep reported there were holes in the packaging of custom made components: "there was a packaging issue with pin22902, operation date 16th march.1.There was a hole in the outer packaging of the rotating component that was noticed before the surgery started.This didn't compromise the operation as they had a mets component on the shelf.2.There was also a hole in both outer and inner wrapping of the custom proximal tibia component.This wasn't noticed until the implant was opened.The surgeon spoke to colleagues and followed advice to clean the custom tibia and implant into the patient.".

Manufacturer Narrative

Reported event: an event regarding packaging issue involving a patient specific, proximal tibial replacement, tibial hinge was reported.The event was not confirmed.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 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.Conclusion: a discussion between the complaints, operations quality packaging team, and sales rep was held.The sales rep reported the following "the hole on the rotating hinge component was found on the paper side of the packaging.The hole on the proximal tibial component was found on the clear side of the packaging (approximately in the middle).- the damage to the rotating hinge component packaging was noticed first by the scrub nurse and was replaced with an ¿off the shelve¿ component." review of the inspection records show device was checked prior irradiation & dispatch and no discrepancies were reported.The sales rep confirmed the packaging for return cannot be found at the hospital, they asked if the device had already returned to stanmore.It was confirmed nothing was returned to stanmore from the hospital.The exact cause of the event could not be determined because insufficient information was provided.Additional information including operative reports, progress notes, and 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: TIBIAL ROTATING COMPONENT
• 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: 14056791
• MDR Text Key: 289973292
• Report Number: 3004105610-2022-00055
• Device Sequence Number: 1
• Product Code: KRO
• Combination Product (y/n): N
• Reporter Country Code: UK
• 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: 06/20/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/08/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 09/30/2022
• Device Catalogue Number: UNK_STM
• Device Lot Number: PIN 22902
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 06/07/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/07/2022
• 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): Other