MAUDE Adverse Event Report: STRYKER GMBH UNKNOWN STRYKER PIP SILICONE IMPLANT -SIZE 30; PROSTHESIS, FINGER, CONSTRAINED, POLYMER

Catalog Number UNK_SEL

Device Problem Break (1069)

Patient Problems Failure of Implant (1924); Loss of Range of Motion (2032); Implant Pain (4561); Swelling/ Edema (4577)

Event Date 11/15/2021

Event Type  Injury  

Event Description

As reported: "patient had the surgery (b)(6) 2020 and a year later the back of ring finger felt swollen and hard, her physician took and x-ray and it showed that the implant had snapped and the bone is "coming out" of the back of patient's finger.Patient can bend the finger a little but it is painful.Patient visited the physician two weeks ago and isn't interested in getting another surgery.Stated that the pain had progressed from when she lasted visited the doctor two weeks ago.".

Manufacturer Narrative

The device will not be returned.If additional information becomes available, it will be provided in a supplemental report.Device is not available; device remains implanted in patient.

• Brand Name: UNKNOWN STRYKER PIP SILICONE IMPLANT -SIZE 30
• Type of Device: PROSTHESIS, FINGER, CONSTRAINED, POLYMER
• Manufacturer (Section D): STRYKER GMBH; bohnackerweg 1; postfach; selzach 2545 ; SZ 2545
• Manufacturer (Section G): STRYKER GMBH; bohnackerweg 1; postfach; selzach 2545 ; SZ 2545
• Manufacturer Contact: sharon rivas ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 12975198
• MDR Text Key: 282037087
• Report Number: 0008031020-2021-00493
• Device Sequence Number: 1
• Product Code: KYJ
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Consumer
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 12/10/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/10/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Catalogue Number: UNK_SEL
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 11/15/2021
• 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
• Patient Age: 73 YR
• Patient Sex: Female
• Patient Weight: 63 KG