MAUDE Adverse Event Report: STRYKER GMBH 20 SILICONE PIP IMPLANT (STERILE PACKED); PROSTHESIS, FINGER, CONSTRAINED, POLYMER23

Catalog Number PIP20

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problems Erythema (1840); Pain (1994); Swelling (2091); Fluid Discharge (2686)

Event Date 08/23/2018

Event Type  Injury  

Manufacturer Narrative

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

Event Description

Setting up autofix screw 2.0.One month after appearance of an inflammatory phenomenon with redness and digital swelling in two patients.Inflammatory reaction and local discomfort for patient: pain, swelling, local fluid drainage.

Manufacturer Narrative

This device is concomitant and did not contribute to the reported failure.If any additional information is provided indicating otherwise the record will be reopened and the investigation will be reworked.

Event Description

Setting up autofix screw 2.0.One month after appearance of an inflammatory phenomenon with redness and digital swelling in two patients.Inflammatory reaction and local discomfort for patient pain, swelling, local fluid drainage.

• Brand Name: 20 SILICONE PIP IMPLANT (STERILE PACKED)
• Type of Device: PROSTHESIS, FINGER, CONSTRAINED, POLYMER23
• Manufacturer (Section D): STRYKER GMBH; bohnackerweg 1; postfach; selzach 2545 ; CH 2545
• MDR Report Key: 7993226
• MDR Text Key: 124655823
• Report Number: 0008031020-2018-00885
• 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: health professional
• Type of Report: Initial,Followup
• Report Date: 11/16/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/22/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Catalogue Number: PIP20
• Device Lot Number: 03091V
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 10/25/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 63 YR