MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH REUNION TSA - SR STANDARD HUMERAL HEAD 44X16; IMPLANT

Catalog Number 5552-S-4416

Device Problem Unintended Movement (3026)

Patient Problem Pain (1994)

Event Date 02/20/2014

Event Type  Injury  

Event Description

It was reported that the patient was being revised due to painful right shoulder.The surgeon noted that the stem was at neutral rotation.

Manufacturer Narrative

A supplemental report will be submitted upon completion of the investigation.

Event Description

It was reported that the patient was being revised due to painful right shoulder.The surgeon noted that the stem was at neutral rotation.

Manufacturer Narrative

An event regarding pain involving a reunion tsa - sr standard humeral head 44x16 was reported.The event was not confirmed.Method and results: device evaluation could not be performed as the subject device was not returned.Medical records received and evaluation: no medical records were received for review with a clinical consultant.Device history review indicated the devices accepted into final stock from the reported lot were free from discrepancies complaint history review: a complaint history review was not performed as no device specific failure modes were identified.Conclusions: the exact cause of the reported pain could not be determined.Based on the information provided there is no evidence the event is device related.A capa trend analysis was conducted for the reported failure mode and concluded pain may result from other factors not necessarily related to the device.

• Brand Name: REUNION TSA - SR STANDARD HUMERAL HEAD 44X16
• Type of Device: IMPLANT
• Manufacturer (Section D): STRYKER ORTHOPAEDICS-MAHWAH; 325 corporate drive; mahwah NJ 07430
• Manufacturer (Section G): STRYKER ORTHOPAEDICS-MAHWAH; 325 corporate drive; mahwah NJ 07430
• Manufacturer Contact: beverly lima ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 3684987
• MDR Text Key: 4255806
• Report Number: 0002249697-2014-00796
• Device Sequence Number: 1
• Product Code: KWS
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K103835
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 02/20/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/18/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 07/31/2016
• Device Catalogue Number: 5552-S-4416
• Device Lot Number: MKL05X
• Other Device ID Number: STERILE LOT MSHKL28A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/04/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/28/2011
• 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: 59 YR