MAUDE Adverse Event Report: STANMORE IMPLANTS WORLDWIDE INT SHAFT & STEM:L=15 D=27 HA; PROSTHESIS, KNEE, FEMOROTIBIAL, CONSTRAINED, CEMENTED, METAL/POLYMER

Catalog Number MSISS-15X27C

Device Problems Device Misassembled During Manufacturing /Shipping (2912); Device-Device Incompatibility (2919)

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

Event Date 02/13/2023

Event Type  malfunction  

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

As reported: "we had an issue with an implant from stanmore.We used a right trochanter and a small integrated stem.When we built up the actual definitive implant the stem on the integral stem was bowed with the tip going laterally, not following the natural bow of the implant.We used the implant as we had no alternative.We opened the next sizes to check if they were correct and to discuss if it was a fault or if we had done anything wrong and the ones that we opened were absolutely fine." update: "the implant was still implanted and as we used an mdm we altered the version manually by rotating the stem within the cement." "slight delay as we compared to trial and tried to reconnect trochanter and stem.".

Event Description

As reported: "we had an issue with an implant from stanmore.We used a right trochanter and a small integrated stem.When we built up the actual definitive implant the stem on the integral stem was bowed with the tip going laterally, not following the natural bow of the implant.We used the implant as we had no alternative.We opened the next sizes to check if they were correct and to discuss if it was a fault or if we had done anything wrong and the ones that we opened were absolutely fine." update: "the implant was still implanted and as we used an mdm we altered the version manually by rotating the stem within the cement." "slight delay as we compared to trial and tried to reconnect trochanter and stem." update: "patient is seemingly doing well.The surgeon has had to over antevert her which can be seen in the x-rays.".

Manufacturer Narrative

Reported event: an event regarding size/fit issue involving a mets, proximal femoral replacement, shaft was reported.The event was confirmed by photographs and x ray review.Method & results: device evaluation and results: visual inspection the stem of the component is bowed towards the left.The device shows no signs of damage or wear.The image also confirms this no wear is seen and the lateral bow appears more prominent in this view.Clinician review: the implant in situ was for mets proximal femoral replacement which was inserted in (b)(6) 2023.The surgeon reported that the tip of the femoral stem was bowed towards lateral, in which the tip of the stem should normally be set towards posterior.The x-ray images provided showed that femoral implant has been rotated anteriorly which made the femoral neck more anteverted in order for the stem to follow the anterior curvature of the bone.Therefore, the radiographic review can confirm the clinical report.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: based on the device identification the complaint databases were reviewed for similar events regarding size/fit issue.There have been no other events for the lot b25367 referenced.Conclusion: the investigation concluded that the size/fit issue was caused by a non-conformance that occurred in manufacturing area while setting the stem.No further investigation is required at this time.If additional information becomes available to indicate further evaluation is warranted, this record will be reopened.Product surveillance will continue to monitor for trends.

• Brand Name: INT SHAFT & STEM:L=15 D=27 HA
• 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: arokiya raj ; 325 corporate drive; centennial park, elstree; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 16517992
• MDR Text Key: 311238054
• Report Number: 3004105610-2023-00034
• Device Sequence Number: 1
• Product Code: KRO
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: K121029
• 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: 10/12/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/09/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: MSISS-15X27C
• Device Lot Number: B25367
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 09/22/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/17/2010
• 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
• Patient Age: 81 YR
• Patient Sex: Female
• Patient Ethnicity: Non Hispanic
• Patient Race: White