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

Catalog Number	PIP20
Health Effect - Clinical Codes	Erythema (1840); Pain (1994); Swelling (2091); Fluid Discharge (2686)
Date of Event	08/23/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Device will not be returned.If additional information becomes available it will be provided on a supplemental report.
Event or Problem 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.
Additional 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 or Problem 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)
• Common Device Name: PROSTHESIS, FINGER, CONSTRAINED, POLYMER23
• Manufacturer (Section D): STRYKER GMBH; bohnackerweg 1; postfach; selzach 2545 ; CH 2545
• MDR Report Key: 7993226
• Report Number: 0008031020-2018-00885
• Device Sequence Number: 288760
• Product Code: KYJ
• UDI-Device Identifier: 00886385021539
• UDI-Public: 00886385021539
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K931588
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 11/16/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Lay User/Patient
• Device Catalogue Number: PIP20
• Device Lot Number: 03091V
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 09/25/2018
• Supplement Date Received by Manufacturer: 10/25/2018
• Initial Report FDA Received Date: 10/22/2018
• Supplement Report FDA Received Date: 11/16/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 63 YR