MAUDE Adverse Event Report: STRYKER GMBH 30 SILICONE PIP IMPLANT (STERILE PACKED); PROSTHESIS, FINGER, CONSTRAINED, POLYMER

Model Number PIP-30

Device Problems Break (1069); Fracture (1260)

Patient Problems Failure of Implant (1924); Joint Dislocation (2374)

Event Date 10/30/2021

Event Type  Injury  

Event Description

The customer reported the following issue: "silicone implant broke off, causing finger to dislocate.The patient required a revision surgery.".

Manufacturer Narrative

Device will not be returned.If additional information becomes available, it will be provided in a supplemental report.Device disposition is unknown.

Event Description

The customer reported the following issue: "silicone implant broke off, causing finger to dislocate.The patient required a revision surgery.".

Manufacturer Narrative

Please note corrections to sections d9/h3 the device was returned, and h6 (method and results codes).The reported event could be confirmed, since the device was returned, and is indeed broken in two.One of the arms of the silicone implant is broken, most probably because of the wear of the material after multiple cycles of flexion-extension.More detailed information about the complaint event such as some patient info (activity levels), x-rays, as well as the implantation date must be available in order to determine the root cause of the complaint event.A review of the device history was not possible because the lot number was not communicated.No corrective actions are required at this time.A review of the labeling did not indicate any abnormalities.No indications of material, manufacturing or design related problems were found during the investigation.If more information is provided, the case will be reassessed.

• Brand Name: 30 SILICONE PIP IMPLANT (STERILE PACKED)
• 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: marilyne chaumont ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 12882905
• MDR Text Key: 281330202
• Report Number: 0008031020-2021-00477
• Device Sequence Number: 1
• Product Code: KYJ
• UDI-Device Identifier: 00886385021553
• UDI-Public: 00886385021553
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K931588
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 04/08/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/29/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: PIP-30
• Device Catalogue Number: PIP30
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/16/2022
• Was Device Evaluated by Manufacturer?: Yes
• 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): Required Intervention; Hospitalization
• Patient Age: 72 YR
• Patient Sex: Male