MAUDE Adverse Event Report: STRYKER GMBH SR MCP, IMPLANT SIZE LARGE; SEMI-CONSTRAINED METAL/POLYMER FINGER JOINT PROSTHESIS

Catalog Number 5800LG00

Device Problem Device Operates Differently Than Expected (2913)

Patient Problem Pain (1994)

Event Date 05/22/2015

Event Type  Injury  

Manufacturer Narrative

Device remains implanted.Additional information was requested and if received will be provided on a supplemental report.

Event Description

Mp joint in left index finger was replaced.I was told by doctor the procedure would result in good mobility, and elimination of joint pain.A year later mobility is good but i still have pain.The implant device came from stryker.

Manufacturer Narrative

The reported event that a stryker mp joint implant led to patient pain 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.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.

Event Description

Mp joint in left index finger was replaced.I was told by doctor the procedure would result in good mobility, and elimination of joint pain.A year later mobility is good but i still have pain.The implant device came from stryker.

• Brand Name: SR MCP, IMPLANT SIZE LARGE
• Type of Device: SEMI-CONSTRAINED METAL/POLYMER FINGER JOINT 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: 5750988
• MDR Text Key: 48245581
• Report Number: 0008031020-2016-00327
• Device Sequence Number: 1
• Product Code: MPK
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: H010001
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 10/19/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 04/30/2019
• Device Catalogue Number: 5800LG00
• Device Lot Number: 23958701
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 06/10/2016
• Initial Date FDA Received: 06/27/2016
• Supplement Dates Manufacturer Received: 10/10/2017
• Supplement Dates FDA Received: 10/19/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/01/2014
• 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: 80 YR
• Patient Weight: 80