MAUDE Adverse Event Report: STRYKER GMBH (MDR) RHEAD RECON STEM IMPLANT NON-COATED, SIZE 1; ELBOW JOINT RADIAL (HEMI-ELBOW) POLYMER PROSTHESIS

Catalog Number RCNS160

Device Problem Device Operates Differently Than Expected (2913)

Patient Problem Unspecified Infection (1930)

Event Date 06/15/2012

Event Type  Injury  

Manufacturer Narrative

The reported event 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 root cause of the complaint event.In the most unlikely case, the device at issue was superficially contaminated due to transportation, but this would not explain and justify the reported late infection.Therefore the latter can be considered extremely unlikely to be due to the device packaging integrity addressed by regulatory action (b)(4).Given the nature of the complaint, device history review was not considered necessary.Device will not be returned.If additional information becomes available it will be provided on a supplemental report.(b)(4).Stryker became legal manufacturer of this product on april 1, 2015 and has taken the responsibility for medical device reporting.Device will not be returned.

Event Description

Due to the regulatory action (b)(4), one of the customers affected, reported that in the past they received product under the scope of this action.While putting their records together, they noticed that there was a patient implanted with one of these lots that was related to an event of patient infection.The patient suffered an infection after the implantation and he was explanted by (b)(6) 2012.The hospital did not report neither the former distributor of (b)(6) nor the competent authorities.

• Brand Name: RHEAD RECON STEM IMPLANT NON-COATED, SIZE 1
• Type of Device: ELBOW JOINT RADIAL (HEMI-ELBOW) POLYMER PROSTHESIS
• Manufacturer (Section D): STRYKER GMBH (MDR); bohnackerweg 1; postfach; selzach 02545 ; CH 02545
• Manufacturer (Section G): STRYKER GMBH (MDR); bohnackerweg 1; postfach; selzach 02545 ; CH 02545
• Manufacturer Contact: rose haas ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 5065206
• MDR Text Key: 25332219
• Report Number: 0008031020-2015-00377
• Device Sequence Number: 1
• Product Code: KWI
• UDI-Device Identifier: 00886385025131
• UDI-Public: 00886385025131
• Combination Product (y/n): N
• Reporter Country Code: SP
• PMA/PMN Number: K023604
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Reporter Occupation: Nurse
• Report Date: 08/17/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/09/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Catalogue Number: RCNS160
• Device Lot Number: 22614101
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/17/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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