MAUDE Adverse Event Report: STRYKER GMBH 10 SILICONE PIP IMPLANT (STERILE PACKED); PROSTHESIS, FINGER, CONSTRAINED, POLYMER

Model Number PIP-10

Device Problem Naturally Worn (2988)

Patient Problems Failure of Implant (1924); Loss of Range of Motion (2032)

Event Date 09/21/2021

Event Type  Injury  

Manufacturer Narrative

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

Event Description

As reported; "implants wore apart within the patients pip joint causing a loss in range of motion.Initial primary surgery provided short term relief but because of how they were implanted the patient lost range of motion over time as silicon replacement wore out.".

• Brand Name: 10 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: sharon rivas ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 12793172
• MDR Text Key: 280891517
• Report Number: 0008031020-2021-00454
• Device Sequence Number: 1
• Product Code: KYJ
• UDI-Device Identifier: 00886385021515
• UDI-Public: 00886385021515
• 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
• Report Date: 11/11/2021

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?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: PIP-10
• Device Catalogue Number: PIP10
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/14/2021
• Initial Date FDA Received: 11/11/2021
• 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): Required Intervention; Hospitalization
• Patient Age: 58 YR
• Patient Sex: Female
• Patient Weight: 66 KG