MAUDE Adverse Event Report: STRYKER GMBH 30 SILICONE PIP IMPLANT (STERILE PACKED); PROSTHESIS, FINGER, CONSTRAINED, POLYMER23

Catalog Number PIP30

Device Problem Break (1069)

Patient Problem Failure of Implant (1924)

Event Date 06/24/2015

Event Type  Injury  

Event Description

It was reported that the patient had a pip implant break.The implant was in for less than 3 months.Sales rep stated that patient went in for follow up and stated they were feeling great and had good movement and upon x-ray it was discovered the implant was broken.

Manufacturer Narrative

Device will not be returned.If additional information becomes available it will be provided on a supplemental report.The reported device was manufactured and distributed by (b)(4) and implanted prior to howmedica osteonics corp.¿s purchase of certain assets of sbi on (b)(6) 2014.Stryker became legal manufacturer of this product on (b)(6) 2015 and has taken the responsibility for medical device reporting.Device will not be returned.

Manufacturer Narrative

The reported event that a 30 silicone pip implant (sterile packed) was alleged of breakage after surgery could not be confirmed, since the device was not returned for evaluation and no other evidences were provided.Based on investigation, the root cause was attributed to a patient related issue.The most likely cause is excessive physical activity and/or abuse.Strenuous loading, excessive mobility, and articular instability all may lead to accelerated wear and eventual failure by fracture of the device.Patients should be made aware of the increased potential for device failure if excessive demands are made upon it.A review of the device history for the reported lot did not indicate any abnormalities.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 the device is returned or if any additional information is provided, the investigation will be reassessed.

Event Description

It was reported that the patient had a pip implant break.The implant was in for less than 3 months.Sales rep stated that patient went in for follow up and stated they were feeling great and had good movement and upon x-ray it was discovered the implant was broken.

• Brand Name: 30 SILICONE PIP IMPLANT (STERILE PACKED)
• Type of Device: PROSTHESIS, FINGER, CONSTRAINED, POLYMER23
• Manufacturer (Section D): STRYKER GMBH; bohnackerweg 1; postfach; selzach 2545 ; CH 2545
• Manufacturer (Section G): STRYKER GMBH; bohnackerweg 1; postfach; selzach 2545 ; CH 2545
• Manufacturer Contact: anna jusinski ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 4915768
• MDR Text Key: 6008986
• Report Number: 0008031020-2015-00304
• Device Sequence Number: 1
• Product Code: KYJ
• 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,health professional
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 06/24/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/15/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Catalogue Number: PIP30
• Device Lot Number: 23987001
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/18/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/30/2014
• 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