MAUDE Adverse Event Report: STRYKER GMBH SR 4MM OFFSET HUMERAL HE AD TRIAL 52X23; SHOULDER JOINT METAL/POLYMER SEMI-CONSTRAINED CEMENTED PROSTHESIS.

Catalog Number 5901-E-5223

Device Problems Break (1069); Component Missing (2306); Detachment of Device or Device Component (2907); Naturally Worn (2988)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 11/15/2018

Event Type  malfunction  

Manufacturer Narrative

The reported event that sr 4mm offset humeral he ad trial 52x23 was alleged of 'instruments - broken, deformed, worn or scratched' could be confirmed.Based on investigation, the root cause was attributed to be other related.The failure was caused by to much applied mechanical force which this trial implant had to undergo over the years.The device inspection revealed the following: the entire three-jaw looking chuck is indeed completely broken at its base, making the device unusable.We do believe that to much applied mechanical force which this trial implant had to undergo over the years has finally resulted in the breakage of the three-jaw looking chuck.Note that this device was manufactured in may 2012 (wear and tear over the years).A review of the device history for the reported lot did not indicate any abnormalities.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

Upon incoming inspection, item was visibly worn.Investigation of the device revealed that the inner pegs were broken off and missing.

• Brand Name: SR 4MM OFFSET HUMERAL HE AD TRIAL 52X23
• Type of Device: SHOULDER JOINT METAL/POLYMER SEMI-CONSTRAINED CEMENTED PROSTHESIS.
• Manufacturer (Section D): STRYKER GMBH; bohnackerweg 1; postfach; selzach 2545 ; CH 2545
• Manufacturer (Section G): STRYKER ORTHOPAEDICS-MAHWAH; 325 corporate drive; mahwah NJ 07430
• Manufacturer Contact: anna jusinski ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 8503031
• MDR Text Key: 142484470
• Report Number: 0008031020-2019-00352
• Device Sequence Number: 1
• Product Code: KWS
• UDI-Device Identifier: 07613327099928
• UDI-Public: 07613327099928
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 04/11/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/11/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Catalogue Number: 5901-E-5223
• Device Lot Number: MAC7K14
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 04/10/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/17/2012
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Other