MAUDE Adverse Event Report: STANMORE IMPLANTS WORLDWIDE UNKNOWN METS PROXIMAL HUMERUS (BAYLEY/WALKER) - HUMERAL SHAFT; PROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER CEMENTED

Catalog Number UNK_STM

Device Problems Loss of Osseointegration (2408); Device Dislodged or Dislocated (2923)

Patient Problems Ambulation Difficulties (2544); Inadequate Osseointegration (2646)

Event Date 06/22/2021

Event Type  Injury  

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

An email from the surgeon stated: m/48 with left proximal humerus dedifferentiated chondrosarcoma.Wide resection of left proximal humerus was performed on (b)(6) 2021.Reconstruction with bayley walker reverse shoulder prosthesis.Tumour tube used for soft tissue repair.Bone-implant junction at humerus augmented with small plate + dallmile cable.Postop implant stable and recovery uneventful, proceeded with adjuvant chemo.He noted left shoulder crepitus sensation and sound in (b)(6) 2021 after taking a break from physiotherapy in (b)(6) 2021.There was no pain or swelling.He had no preceding injury.Left shoulder range of motion: abduction 90 deg, external rotation & internal rotation 40 deg.Screening under image intensifier showed loosening of the humeral component-shaft interface of the humerus prosthesis.It was distractible with gravity or weak distraction force and reducible with axial load c-reactive protein level was normal.Although the condition is not painful, the patient is not able to use his left upper limb well currently and would like to have this issue fixed.

Manufacturer Narrative

Reported event: an event regarding disassociation involving a mets, bayley walker, proximal humeral replacement, shaft 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: a review of the provided x-rays by clinical consultant indicated: the implant in situ was for a mets proximal humeral replacement, which was inserted on (b)(6) 2021.The surgeon reported loosening of the component-shaft interface of the humerus prosthesis.The images provided show an enlarged gap between the humeral component and shaft, which confirms the clinical report.This is a very rare situation and the cause of this is unclear.Device history review: could not be performed as lot code information was not provided.Complaint history review: could not be performed as lot code information was not provided.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, 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.Product surveillance will continue to monitor for trends.

Event Description

An email from the surgeon stated : - m/48 with left proximal humerus dedifferentiated chondrosarcoma.Wide resection of left proximal humerus was performed on (b)(6) 2021.Reconstruction with bayley walker reverse shoulder prosthesis.Tumour tube used for soft tissue repair.Bone-implant junction at humerus augmented with small plate + dallmile cable.Postop implant stable and recovery uneventful, proceeded with adjuvant chemo.He noted left shoulder crepitus sensation and sound in (b)(6) 2021 after taking a break from physiotherapy in (b)(6) 2021.There was no pain or swelling.He had no preceding injury.Left shoulder range of motion: abduction 90 deg, external rotation & internal rotation 40 deg.Screening under image intensifier showed loosening of the humeral component-shaft interface of the humerus prosthesis.It was distractible with gravity or weak distraction force and reducible with axial load c-reactive protein level was normal.Although the condition is not painful, the patient is not able to use his left upper limb well currently and would like to have this issue fixed.Update (b)(6) 2021: "we had a call with the surgeon and i can confirm that the shaft has dissociated from the humeral body at the taper junction".

• Brand Name: UNKNOWN METS PROXIMAL HUMERUS (BAYLEY/WALKER) - HUMERAL SHAFT
• Type of Device: PROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER CEMENTED
• 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: 12164887
• MDR Text Key: 261474075
• Report Number: 3004105610-2021-00108
• Device Sequence Number: 1
• Product Code: KWS
• Combination Product (y/n): N
• Reporter Country Code: HK
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 11/08/2021

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 Catalogue Number: UNK_STM
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 06/22/2021
• Initial Date FDA Received: 07/14/2021
• Supplement Dates Manufacturer Received: 10/29/2021
• Supplement Dates FDA Received: 11/08/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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): Hospitalization; Required Intervention
• Patient Sex: Male