MAUDE Adverse Event Report: STANMORE IMPLANTS WORLDWIDE HUM INT. SHFT & STM COATD L:19; PROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER CEMENTED

Catalog Number MHISS-8C

Device Problems Detachment of Device or Device Component (2907); Unintended Movement (3026)

Patient Problems Pain (1994); Loss of Range of Motion (2032)

Event Date 11/30/2022

Event Type  Injury  

Event Description

As reported by surgeon, regarding a right mets bayley-walker proximal humeral replacement: "the operation went well.Except that there's a bit of excessive retroversion hence there's some limitation of internal rotation.Now it is 6 weeks post-operation.However in the last 2 weeks the patient complained of some noise when moving the shoulder.X-ray today shows that the trunnion loosened and telescoped downwards.It could be reduced manually but cannot stay there.During the operation at the time of assembly of the components, i followed the instruction on the manual, and tried pulling the components apart and it was snug at the time.What could be the cause of such an event? what's the incidence of this in the past? any recommendations as to what to do?" update (b)(6) 2022 wg: per surgeon, instability, discomfort, and the possibility of a revision are also reported.Per surgeon: "there's no history of accidental fall or strenuous use.In fact due to version issue the arm was placed in an abduction external rotation brace for 6 weeks.It is at around 4-6 weeks that the trunnion loosening happened.There could be a bit of excessive retroversion of the glenoid during insertion, while the humeral component version is probably just right or slightly over (retroversion).Hence after cementation the arm can only go to neutral rotation and no further, beyond which and before insertion of the captive ring it would dislocate.After insertion of the restraining ring and reinforcement mesh (in the manner after mr bayley technique) the joint would not dislocate, but just cannot go beyond neutral.It is because of this that we keep the arm in er and abduction for protection.I suppose this could lead to ?excessive stress across the trunnion.As for insertion technique, i followed exactly the protocol with assistant's hand holding the implant and then deliver several sharp blows.I tested the articulation on table and it feels snug and cannot be pulled apart." update (b)(6) 2022 wg: additional information from surgeon: some additional and perhaps important information: i forgot to mention that the patient is a case of ca cervix with pathological fracture of proximal humerus pre-op.She was treated with chemotherapy and the arm was kept in a poly sling for 3 months.The fracture subsequently healed before operation, but i believe due to prolonged bracing in an internal rotated position, there's an inherent malrotation pre-op.This could have led to the slightly increased retroversion of the humeral component i mentioned in my previous email.

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 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.Catalog numbers and lot codes of other devices listed in this report: mphbw-ru prox hum comp uncoated r/s humeral component - mets bayley walker ph lot a26760 wbgc01 bayley/walker glenoid comp sml lot b30079 it cannot be determined which, if any of these devices may have caused or contributed to the patient's experience.

Manufacturer Narrative

An event regarding disassociation involving a shaft - mets bayley/walker proximal humeral replacement 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 mets bayley/walker proximal humeral replacement which was inserted on (b)(6) 2022.The surgeon reported that the stem/shaft trunnion loosened and telescoped downwards.One of the x-ray images (both images have no date) provided showed that the stem/shaft was disengaged downwards indicating the trunnion was loose.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: 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 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.

Event Description

As reported by surgeon, regarding a right mets bayley-walker proximal humeral replacement: "the operation went well.Except that there's a bit of excessive retroversion hence there's some limitation of internal rotation.Now it is 6 weeks post-operation.However in the last 2 weeks the patient complained of some noise when moving the shoulder.X-ray today shows that the trunnion loosened and telescoped downwards.It could be reduced manually but cannot stay there.During the operation at the time of assembly of the components, i followed the instruction on the manual, and tried pulling the components apart and it was snug at the time.What could be the cause of such an event? what's the incidence of this in the past? any recommendations as to what to do?".Update 02/december/2022 wg: per surgeon, instability, discomfort, and the possibility of a revision are also reported.Per surgeon: "there's no history of accidental fall or strenuous use.In fact due to version issue the arm was placed in an abduction external rotation brace for 6 weeks.It is at around 4-6 weeks that the trunnion loosening happened.There could be a bit of excessive retroversion of the glenoid during insertion, while the humeral component version is probably just right or slightly over (retroversion).Hence after cementation the arm can only go to neutral rotation and no further, beyond which and before insertion of the captive ring it would dislocate.After insertion of the restraining ring and reinforcement mesh (in the manner after mr bayley technique) the joint would not dislocate, but just cannot go beyond neutral.It is because of this that we keep the arm in er and abduction for protection.I suppose this could lead to ?excessive stress across the trunnion.As for insertion technique, i followed exactly the protocol with assistant's hand holding the implant and then deliver several sharp blows.I tested the articulation on table and it feels snug and cannot be pulled apart.".Update 04/december/2022 wg: additional information from surgeon: some additional and perhaps important information: i forgot to mention that the patient is a case of ca cervix with pathological fracture of proximal humerus pre-op.She was treated with chemotherapy and the arm was kept in a poly sling for 3 months.The fracture subsequently healed before operation, but i believe due to prolonged bracing in an internal rotated position, there's an inherent malrotation pre-op.This could have led to the slightly increased retroversion of the humeral component i mentioned in my previous email.

• Brand Name: HUM INT. SHFT & STM COATD L:19
• 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: 15994245
• MDR Text Key: 305584449
• Report Number: 3004105610-2022-00167
• 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: Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 02/27/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/16/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: MHISS-8C
• Device Lot Number: B30079
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/23/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/01/2020
• 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: 50 YR
• Patient Sex: Female