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

Catalog Number 5800MD00

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problem Perforation (2001)

Event Date 09/08/2016

Event Type  Injury  

Manufacturer Narrative

(b)(4).Device will not be returned.If additional information becomes available it will be provided on a supplemental report.Patient keep the device.

Event Description

The silicone part of the joint perforated through the bone towards the palm arm.The joint slipped off and had to be extracted and replaced.

Manufacturer Narrative

The reported event that sr mcp, implant size medium was alleged of 'late or non-healing' could be confirmed.Based on provided x-rays, we can confirm the palmar bone perforation.However, the submitted x-rays do not allow for clarification of the root cause.A silicone implant is not expected to be able to perforate an intact cortical bone.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

The silicone part of the joint perforated through the bone towards the palm arm.The joint slipped off and had to be extracted and replaced.

• Brand Name: SR MCP, IMPLANT SIZE MEDIUM
• 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: 6289144
• MDR Text Key: 66125028
• Report Number: 0008031020-2017-00052
• Device Sequence Number: 1
• Product Code: MPK
• Combination Product (y/n): N
• 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: 01/19/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/31/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 12/31/2016
• Device Catalogue Number: 5800MD00
• Device Lot Number: 22847801
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 01/12/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/14/2012
• 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: 40 YR