MAUDE Adverse Event Report: STRYKER GMBH MCPX-20; PROSTHESIS, FINGER, CONSTRAINED, POLYMER

Model Number MCPX-20

Device Problem Fracture (1260)

Patient Problem Failure of Implant (1924)

Event Date 10/01/2020

Event Type  Injury  

Manufacturer Narrative

The reported event could not be confirmed, since the device was not returned for evaluation and no other additional information is available.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.If any further information is provided, the investigation report will be updated.

Event Description

The manufacturer became aware of a post market clinical follow-up report received from (b)(6).The title of this report is ¿a retrospective data collection of the treatment of degenerative or post-traumatic disabilities in the metacarpophalangeal (mcp) and proximal interphalangeal (pip) joints with the silicone and preflex prostheses¿ which is associated with the stryker ¿silicone pip and preflex mcp¿ prosthesis.This study includes research done on (b)(6) patients (142 implants) requiring surgery between the period 2007 and 2019.It was not possible to ascertain specific device details from the report, or to match the events reported with previously reported complaints.Therefore, new complaint was initiated in the system for the post-operative complication mentioned in the report.This product inquiry addresses rupture of d3 prostheses diagnosed 129 months after the first implantation (radiographic control-ulnar off-axis, rupture) which was reimplanted on 09/03/2019.The report states: ¿the fourth patient was initially implanted with two mcps, d2 and d3.The diagnosis of rupture for these two prostheses was made 129 months after the first implantation.In this case, the patient presented for a consultation concerning the mcp joints of fingers d4 and d5, and the diagnosis of ruptures of d2 and d3 was therefore established by chance during the pre-operative x-ray.In this configuration, the patient was not aware of the loss of range of motion, and had no pain.In this case, the 129-month duration of the prosthesis' survivorship is not to be taken into account.¿.

Event Description

The manufacturer became aware of a post market clinical follow-up report received from urgence main mulhouse, clinique du diaconat, in france.The title of this report is ¿a retrospective data collection of the treatment of degenerative or post-traumatic disabilities in the metacarpophalangeal (mcp) and proximal interphalangeal (pip) joints with the silicone and preflex prostheses¿ which is associated with the stryker ¿silicone pip and preflex mcp¿ prosthesis.This study includes research done on 109 patients (142 implants) requiring surgery between the period 2007 and 2019.It was not possible to ascertain specific device details from the report, or to match the events reported with previously reported complaints.Therefore, new complaint was initiated in the system for the post-operative complication mentioned in the report.This product inquiry addresses rupture of d3 prostheses diagnosed 129 months after the first implantation (radiographic control-ulnar off-axis, rupture) which was reimplanted on (b)(6) 2019.The report states: ¿the fourth patient was initially implanted with two mcps, d2 and d3.The diagnosis of rupture for these two prostheses was made 129 months after the first implantation.In this case, the patient presented for a consultation concerning the mcp joints of fingers d4 and d5, and the diagnosis of ruptures of d2 and d3 was therefore established by chance during the pre-operative x-ray.In this configuration, the patient was not aware of the loss of range of motion, and had no pain.In this case, the 129-month duration of the prosthesis' survivorship is not to be taken into account.¿.

Manufacturer Narrative

The reported event could not be confirmed, since the device was not returned for evaluation and no other additional information is available.This complaint has been reported during a literature review performed by the post market surveillance group.No product identification is possible as the affected device was not returned.A review of the device history for the reported lot did not indicate any abnormalities.No corrective actions are required at this time.More detailed information about the complaint event as well as the affected device must be available to determine the root cause of the complaint event.Based on the investigation, no definitive relation could be established between the product and the reported failure adverse consequence.If any further information is provided, the investigation report will be updated.

• Brand Name: MCPX-20
• Type of Device: PROSTHESIS, FINGER, CONSTRAINED, POLYMER
• Manufacturer (Section D): STRYKER GMBH; bohnackerweg 1; postfach; selzach 2545 ; SZ 2545
• MDR Report Key: 10777699
• MDR Text Key: 216849188
• Report Number: 0008031020-2020-02383
• Device Sequence Number: 1
• Product Code: KYJ
• UDI-Device Identifier: 00886385025339
• UDI-Public: 00886385025339
• Combination Product (y/n): N
• PMA/PMN Number: K013629
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: study
• Type of Report: Initial,Followup
• Report Date: 01/13/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/03/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 06/01/2012
• Device Model Number: MCPX-20
• Device Catalogue Number: MCPX20
• Device Lot Number: 39164001
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 12/17/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 37 YR