MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH UNKNOWN RT. HUMERAL STEM; ELBOW IMPLANT

Catalog Number UNK_REC

Device Problems Loss of or Failure to Bond (1068); Insufficient Information (3190)

Patient Problem No Information (3190)

Event Date 12/16/2015

Event Type  Injury  

Manufacturer Narrative

An evaluation of the device cannot be performed as the device was not returned to the manufacturer due to hospital policy.Additional information has been requested.Should additional information become available it will be reported in a supplemental report upon completion of the investigation.

Event Description

It was reported that surgeon revised patients' right elbow due to pain and a loose humeral stem as shown on radiograph.Radiographic lines indicated loosening of device.

Manufacturer Narrative

An event regarding revision due pain and stem loosening involving an unknown right humeral stem was reported.The event was not confirmed.Method and results: device evaluation and results: photographs of devices were provided.The humeral stem appears to be intact and connected to the distal humeral implant.Conclusions: the event could not be confirmed nor the root cause determined because the devices were not returned for evaluation and no medical information was provided.If the devices and/or additional information are received, this investigation will be reopened and re-evaluated.

Event Description

It was reported that surgeon revised patients' right elbow due to pain and a loose humeral stem as shown on radiograph.Radiographic lines indicated loosening of device.

• Brand Name: UNKNOWN RT. HUMERAL STEM
• Type of Device: ELBOW 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: keyla colon ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 5371091
• MDR Text Key: 36198811
• Report Number: 0002249697-2016-00091
• Device Sequence Number: 1
• Product Code: KWI
• 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,other
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 12/18/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/15/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 11/30/2002
• Device Catalogue Number: UNK_REC
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/26/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/30/2002
• 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: 61 YR