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

Catalog Number PIP40

Device Problems Degraded (1153); Device Dislodged or Dislocated (2923)

Patient Problems Pain (1994); Injury (2348)

Event Date 08/31/2019

Event Type  Injury  

Manufacturer Narrative

Upon completion of investigation, additional information will be provided in a supplemental report.

Event Description

A pip implant 40 was placed on (b)(6) 2019.The customer reported the following: primary operation date: (b)(6) 2018 - placement pip implant 40.After a while, the patient was having pain complaints and then an operation was scheduled ((b)(6) 2019).This showed that the original implant was no longer intact.There is a considerable defect in the joint of the implant.A new pip implant has been placed.

Event Description

A pip implant 40 was placed on 31 august 2019.The customer reported the following: primary operation date: (b)(6) 2018 - placement pip implant 40.After a while, the patient was having pain complaints and then an operation was scheduled ((b)(6) 2019).This showed that the original implant was no longer intact.There is a considerable defect in the joint of the implant.A new pip implant has been placed.

Manufacturer Narrative

The reported event could be confirmed.The visual inspection showed that the returned implant is severely damaged (multiple scratches were noticed).The part is indeed fractured.More detailed information about the complaint event (such as x-rays pre and post operative) 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.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 any further information is provided, the investigation report will be updated.

• Brand Name: 40 SILICONE PIP IMPLANT (STERILE PACKED)
• Type of Device: PROSTHESIS, FINGER, CONSTRAINED, POLYMER
• Manufacturer (Section D): STRYKER GMBH; bohnackerweg 1; postfach; selzach 2545 ; CH 2545
• MDR Report Key: 9159401
• MDR Text Key: 167706024
• Report Number: 0008031020-2019-01360
• Device Sequence Number: 1
• Product Code: KYJ
• UDI-Device Identifier: 00886385021577
• UDI-Public: 00886385021577
• Combination Product (y/n): N
• PMA/PMN Number: K931588
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other
• Type of Report: Initial,Followup
• Report Date: 12/27/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/04/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 03/31/2022
• Device Catalogue Number: PIP40
• Device Lot Number: 00696L
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/07/2019
• Date Manufacturer Received: 12/27/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention