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

Model Number PIP-20

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Loss of Range of Motion (2032)

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.Device disposition is unknown.

Event Description

The manufacturer became aware of a post market clinical follow-up report received from (b)(6), in (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 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 stiffness (pip at d2) for which tenoarthrolysis was done later.

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 stiffness (pip at d2) for which tenoarthrolysis was done later.

Manufacturer Narrative

Correction: refer to d4 lot number, h6 method code.The reported event could not be confirmed, since the device was not returned for evaluation and no other evidences were provided.This complaint has been reported during a literature review performed by the post market surveillance group.No product identification is possible with the available information.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.As per the event description ¿stiffness¿ mentioned in the literature.As no further information provided it can be concluded that the factors influenced ¿stiffness¿ might not be device related but probably linked to patient factors, poor surgical technique or failure in compliance of post-operative procedure (behavioral) requirement.If any further information is provided, the investigation report will be updated.

• Brand Name: PIP-20
• Type of Device: PROSTHESIS, FINGER, CONSTRAINED, POLYMER
• Manufacturer (Section D): STRYKER GMBH; bohnackerweg 1; postfach; selzach 2545 ; SZ 2545
• MDR Report Key: 10778536
• MDR Text Key: 214369448
• Report Number: 0008031020-2020-02392
• Device Sequence Number: 1
• Product Code: KYJ
• UDI-Device Identifier: 00886385021539
• UDI-Public: 00886385021539
• Combination Product (y/n): N
• PMA/PMN Number: K931588
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: study
• Type of Report: Initial,Followup
• Report Date: 01/14/2021

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?: No
• Device Operator: Lay User/Patient
• Device Model Number: PIP-20
• Device Catalogue Number: PIP20
• Device Lot Number: UNKNOWN
• 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): Other; Required Intervention
• Patient Age: 76 YR