MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH REUNION HA FRACTURE STEM 7MM; PROSTHESIS, SHOULDER, HEMI-, HUMERAL, METALLIC UNCEMENTED

Catalog Number R5351-4507

Device Problem Noise, Audible (3273)

Patient Problem Pain (1994)

Event Date 09/15/2015

Event Type  Injury  

Manufacturer Narrative

It was noted that the device is not available for evaluation.A review of the device history records indicate that devices were manufactured and accepted into final stock with no reported discrepancies.There have been no other events for the lot referenced.If additional information is received, it will be provided in a supplemental report upon completion of the investigation.

Event Description

Patient called stating she had a left shoulder replacement done on (b)(6) 2015.Patient reported pain, and she feels her shoulder clicking always.

• Brand Name: REUNION HA FRACTURE STEM 7MM
• Type of Device: PROSTHESIS, SHOULDER, HEMI-, HUMERAL, METALLIC UNCEMENTED
• 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: sharon rivas ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 8471953
• MDR Text Key: 140586023
• Report Number: 0002249697-2019-01500
• Device Sequence Number: 1
• Product Code: HSD
• UDI-Device Identifier: 07613327139235
• UDI-Public: 07613327139235
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K070963
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,other
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 04/01/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/01/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 03/31/2014
• Device Catalogue Number: R5351-4507
• Device Lot Number: T2T72836-H
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 03/05/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/06/2009
• 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
• Patient Age: 64 YR
• Patient Weight: 77