MAUDE Adverse Event Report: STRYKER GMBH LATERAL ASSEMBLY, RADIAL IMPLANT, SIZE 1; ELBOW JOINT RADIAL (HEMI-ELBOW) POLYMER PROSTHESIS

Catalog Number 3100000

Device Problems Loose or Intermittent Connection (1371); Defective Device (2588)

Patient Problem Pain (1994)

Event Date 10/06/2016

Event Type  Injury  

Manufacturer Narrative

Based on updated information, complaint investigation has been re-assessed and conclusions remain unchanged.The reported event that a radial head implant did not work properly could not be confirmed, since the device was not returned for evaluation and no other evidences were provided.More detailed information about the complaint event as well as the affected device must be available in order to determine the precise root cause of the complaint event.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.Device not available.

Event Description

A surgeon customer complained that a radial head implant did not work properly.Update 26-sept-2018: "it¿s alleged by the attorney, through the filing of a legal claim, that the patient had a stryker lateral head and stem elbow implanted on or about (b)(6) 2016.It is further alleged that after his elbow replacement, he began to experience increasing pain and decreased function.He then visited his orthopedic doctor who confirmed loosening of the radial head components and recommended immediate revision surgery, which took place on or about (b)(6) 2016.Within one week of his revision surgery, the claimant had to undergo re-revision of the radial head component on or about (b)(6) 2016 due to the component coming loose and dislodging for a second time." this pi is for revision of primary.

• Brand Name: LATERAL ASSEMBLY, RADIAL IMPLANT, SIZE 1
• Type of Device: ELBOW JOINT RADIAL (HEMI-ELBOW) POLYMER PROSTHESIS
• Manufacturer (Section D): STRYKER GMBH; bohnackerweg 1; postfach; selzach 2545 ; CH 2545
• Manufacturer (Section G): STRYKER GMBH; bohnackerweg 1; postfach; selzach 2545 ; CH 2545
• Manufacturer Contact: anna jusinski ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 7914645
• MDR Text Key: 121914727
• Report Number: 0008031020-2018-00657
• Device Sequence Number: 1
• Product Code: KWI
• UDI-Device Identifier: 00886385022673
• UDI-Public: 00886385022673
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K062898
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 09/27/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/27/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 09/30/2020
• Device Catalogue Number: 3100000
• Device Lot Number: 24880201
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 09/26/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/23/2015
• 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