MAUDE Adverse Event Report: STANMORE IMPLANTS WORLDWIDE TOTAL HUMERAL REPLACEMENT MINIMALLY INVASIVE GROWER (MIG); PROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER CEMENTED

Catalog Number UNK_STM

Device Problem Device Dislodged or Dislocated (2923)

Patient Problems Muscular Rigidity (1968); Joint Dislocation (2374)

Event Date 02/15/2022

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.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.

Event Description

A patient specific implant prescription form was received for the patient's right total shoulder replacement.Noted on the form: "muscle contracture, joint luxation.Bw shoulder, flexi elbow." proposed date of surgery is blank.Additional information provided by the rep: "the patient has an elbow muscle contracture and humeral joint luxation, retraction didn't help.".

Event Description

A patient specific implant prescription form was received for the patient's right total shoulder replacement.Noted on the form: "muscle contracture, joint luxation.Bw shoulder, flexi elbow." proposed date of surgery is blank.Additional information provided by the rep: "the patient has an elbow muscle contracture and humeral joint luxation, retraction didn't help.".

Manufacturer Narrative

Reported event: an event regarding dislocation involving a mig, total 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 mig total humeral replacement which was inserted on (b)(6) 2017.The surgeon reported muscle contracture, joint luxation, bw shoulder, flexi elbow.The ct image provided shows that the hemi shoulder had subluxation superiorly and laterally.The elbow joint was slightly in flexion, which might be caused by muscle contraction but cannot be confirmed.Therefore, the radiographic review can support some of the clinical reports and reasons for revision.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 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, 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: TOTAL HUMERAL REPLACEMENT MINIMALLY INVASIVE GROWER (MIG)
• 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: 13714860
• MDR Text Key: 286959986
• Report Number: 3004105610-2022-00022
• Device Sequence Number: 1
• Product Code: KWS
• Combination Product (y/n): N
• Reporter Country Code: RS
• 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: 05/13/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/09/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 09/30/2017
• Device Catalogue Number: UNK_STM
• Device Lot Number: PIN 20573
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/27/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/08/2017
• 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: 14 YR
• Patient Sex: Male