MAUDE Adverse Event Report: STRYKER GMBH PROXIMAL INTERPHALANGEAL IMPLANT, SIZE 3; SEMI-CONSTRAINED METAL/POLYMER FINGER JOINT PROSTHESIS

Catalog Number SRPIP3

Device Problem Particulates (1451)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 06/24/2013

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

Residue found on implants prior to surgery - testing confirms particulate to be from foam insert.Foam insert manufacturer has identified and implemented process improvements to mitigate the foam particulate.

• Brand Name: PROXIMAL INTERPHALANGEAL IMPLANT, SIZE 3
• 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: rose haas ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 5319784
• MDR Text Key: 34816107
• Report Number: 0008031020-2015-00599
• Device Sequence Number: 1
• Product Code: MPK
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: H980002
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 06/24/2013

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/22/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: SRPIP3
• Device Lot Number: 2321801
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/24/2013
• 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): Other