MAUDE Adverse Event Report: TORNIER INC UNKNOWN PERFORM HUMERAL STEM; PROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER CEMENTED

Catalog Number UNK_WTB

Device Problems Loss of Osseointegration (2408); Migration (4003)

Patient Problem Insufficient Information (4580)

Event Date 07/15/2022

Event Type  malfunction  

Event Description

X-rays show that the perform humeral stem has subsided from the index x-ray.Timing of subsidence is unknown.Further discussions will take place in case that further action is needed.

Manufacturer Narrative

The reported event could be confirmed, since a medical review of the provided x-rays by a hcp, determined that there was evidence of subsidence of the humeral component.Device was not returned, due to unknown reasons.The device inspection revealed the following: since data was provided, the opinion of a medical expert was sought and stated as follows: "the first x-ray show a well-placed reverse shoulder prosthesis in situation of fairly osteopenic bone of the humerus.The radiopaque elements projected over the shoulder region belong to a bra strap, making this most likely a shoulder belonging to a female.The second x-ray shows clear subsidence of the humeral component, with slight sclerosis around it, indicating the defense of the bone against the loose humeral stem.The glenoid component and adjacent bone are not affected, making a periprosthetic joint infection unlike, yet only tissue cultures taken during revision may exclude infection eventually.Conclusion: subsidence/loosening of the humeral stem, most likely aseptic and due to poor bone quality of the proximal humerus.¿ based on investigation, the root cause was attributed to a patient factors issue.The failure was caused by poor bone quality.A review of the device history was not possible because the lot number was not communicated.No corrective actions are required at this time.A review of the labeling did not indicate any abnormalities.No indications of material, manufacturing or design related problems were found during the investigation.If the device is returned or if any additional information is provided, the investigation will be reassessed.

Manufacturer Narrative

The reported event could be confirmed, since a medical review of the provided x-rays by a hcp, determined that there was evidence of subsidence of the humeral component.Device was not returned, due to unknown reasons.The clinical operations team has already performed at least 2 attempts to the investigation site in order to collect data related to this patient case.All available information is already documented within the complaint/pi.The device inspection revealed the following: since data was provided, the opinion of a medical expert was sought and stated as follows: the first x-ray show a well-placed reverse shoulder prosthesis in situation of fairly osteopenic bone of the humerus.The radiopaque elements projected over the shoulder region belong to a bra strap, making this most likely a shoulder belonging to a female.The second x-ray shows clear subsidence of the humeral component, with slight sclerosis around it, indicating the defense of the bone against the loose humeral stem.The glenoid component and adjacent bone are not affected, making a periprosthetic joint infection unlike, yet only tissue cultures taken during revision may exclude infection eventually.Conclusion: subsidence/loosening of the humeral stem, most likely aseptic and due to poor bone quality of the proximal humerus.¿ based on investigation, the root cause was attributed to a patient factors issue.The failure was caused by poor bone quality.A review of the device history was not possible because the lot number was not communicated.No corrective actions are required at this time.A review of the labeling did not indicate any abnormalities.No indications of material, manufacturing or design related problems were found during the investigation.If the device is returned or if any additional information is provided, the investigation will be reassessed.

Event Description

X-rays show that the perform humeral stem has subsided from the index x-ray.Timing of subsidence is unknown.Further discussions will take place in case that further action is needed.

• Brand Name: UNKNOWN PERFORM HUMERAL STEM
• Type of Device: PROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER CEMENTED
• Manufacturer (Section D): TORNIER INC; 10801 nesbitt avenue s; bloomington MN 55437
• Manufacturer (Section G): TORNIER INC; 10801 nesbitt avenue s; bloomington MN 55437
• Manufacturer Contact: anna jusinski ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 15210997
• MDR Text Key: 297951310
• Report Number: 0001649390-2022-00051
• Device Sequence Number: 1
• Product Code: KWS
• Combination Product (y/n): N
• Reporter Country Code: US
• 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: 09/19/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/11/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Catalogue Number: UNK_WTB
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/23/2022
• 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): Other