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

Catalog Number	PIP40
Medical Device Problem Code	Degraded (1153)
Health Effect - Clinical Codes	Pain (1994); Injury (2348)
Date of Event	08/31/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Upon completion of investigation, additional information will be provided in a supplemental report.
Event or Problem 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 or Problem 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.
Additional 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)
• Common Device Name: PROSTHESIS, FINGER, CONSTRAINED, POLYMER
• Manufacturer (Section D): STRYKER GMBH; bohnackerweg 1; postfach; selzach 2545 ; CH 2545
• MDR Report Key: 9159401
• Report Number: 0008031020-2019-01360
• Device Sequence Number: 2592086
• Product Code: KYJ
• UDI-Device Identifier: 00886385021577
• UDI-Public: 00886385021577
• Combination Product (Y/N): N
• Initial Reporter Country: NL
• PMA/510(K) Number: K931588
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: other
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 12/27/2019

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
• Operator of Device: 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
• Initial Date Received by Manufacturer: 09/10/2019
• Supplement Date Received by Manufacturer: 12/27/2019
• Initial Report FDA Received Date: 10/04/2019
• Supplement Report FDA Received Date: 12/27/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention