MAUDE Adverse Event Report: TORNIER INC TORNIER PERFORM REVERSED STAND ARD BASEPLATE 25MM; PROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER CEMENTED

Model Number DWJ401

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Ossification (1428); Loss of Range of Motion (2032); Implant Pain (4561)

Event Date 07/28/2022

Event Type  Injury  

Manufacturer Narrative

The reported event could not be confirmed since the device was not returned for evaluation and no other evidences were provided.Since this event is a particular issue, the opinion of the medical expert was requested with the limited information available and stated as following: ¿as the surgeon performed an extensive release of soft tissues and the motion interfaces (arthroscopic debridement, capsular release, subacromial decompression, exostosis, removal of posterolateral acromion, and removal of sutures), i do not believe we can blame to inferior osteophyte to be the reason for the limited range of motion.The shoulder was still fine a couple of months before the ae was reported and osteophytes do not develop in such a short time".Moreover, an osteophyte can be defined as a bony outgrowth, that occurred usually adjacent to an area of articular cartilage damage in a joint, mainly affected by osteoarthritis or due to aging, a condition that causes joints to become painful and stiff.In this case, it is very unlikely that the device could have caused the reported event.¿ more detailed information about the complaint event as well as the affected device must be available to determine the root cause of the complaint event.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 any further information is provided, the complaint report will be updated.

Event Description

It was reported that the patient had post-operative pain which limited their range of motion.Through ct scans it was revealed that the patient had inferior osteophyte.The patient underwent an arthroscopic surgery without component extraction.

• Brand Name: TORNIER PERFORM REVERSED STAND ARD BASEPLATE 25MM
• 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: 15727661
• MDR Text Key: 303047785
• Report Number: 0001649390-2022-00092
• Device Sequence Number: 1
• Product Code: KWS
• UDI-Device Identifier: 00846832092116
• UDI-Public: 00846832092116
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K161742
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Study
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 11/03/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/04/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: DWJ401
• Device Catalogue Number: DWJ401
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 10/05/2022
• 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): Required Intervention
• Patient Age: 75 YR
• Patient Sex: Female
• Patient Weight: 54 KG