MAUDE Adverse Event Report: STRYKER GMBH 40 SILICONE PIP IMPLANT (STERILE PACKED); PROSTHESIS, FINGER, CONSTRAINED, POLYMER23

Catalog Number PIP40

Device Problem Material Discolored (1170)

Patient Problem No Code Available (3191)

Event Date 11/06/2015

Event Type  Injury  

Manufacturer Narrative

(b)(4).Device will not be returned.If additional information becomes available it will be provided on a supplemental report.Unknown silicone pip implant.Device will not be returned.

Event Description

It is reported by the surgeon, that 2 years after implantation the prosthesis was completely resolved, dark yellow discoloration.

Manufacturer Narrative

The reported incident that 40 silicone pip implant (sterile packed) was alleged of issue s-22 (material degraded) could not be confirmed, since the device was not returned for evaluation and no other evidences were provided.More detailed information about the complaint event as well as the affected device must be available in order to determine the root cause of the complaint event.A review of the device history for the reported lot did not indicate any abnormalities.The materials used for the parts meet all specifications required and physical and/or chemical test reports are correct.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 is reported by the surgeon, that 2 years after implantation the prosthesis was completely resolved, dark yellow discoloration.

• Brand Name: 40 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: 5240276
• MDR Text Key: 31762399
• Report Number: 0008031020-2015-00468
• Device Sequence Number: 1
• Product Code: KYJ
• Combination Product (y/n): N
• Reporter Country Code: CH
• 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: 01/04/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/20/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 11/30/2015
• Device Catalogue Number: PIP40
• Device Lot Number: 22152806
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/06/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/03/2011
• 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