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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: STRYKER GMBH 20 SILICONE PIP IMPLANT (STERILE PACKED); PROSTHESIS, FINGER, CONSTRAINED, POLYMER
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STRYKER GMBH 20 SILICONE PIP IMPLANT (STERILE PACKED); PROSTHESIS, FINGER, CONSTRAINED, POLYMER Back to Search Results
Model Number PIP-20
Medical Device Problem Code Naturally Worn (2988)
Health Effect - Clinical Code Failure of Implant (1924)
Date of Event 07/14/2021
Type of Reportable Event Serious Injury
Additional 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 or Problem Description
It was reported the patient had revision surgery due to wear and tear on the implant.The original surgery occurred approximately 10 years ago.
 
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Brand Name
20 SILICONE PIP IMPLANT (STERILE PACKED)
Common Device Name
PROSTHESIS, FINGER, CONSTRAINED, POLYMER
Manufacturer (Section D)
STRYKER GMBH
bohnackerweg 1
postfach
selzach 2545
SZ  2545
MDR Report Key12358173
Report Number0008031020-2021-00372
Device Sequence Number3936780
Product Code KYJ
UDI-Device Identifier00886385021539
UDI-Public00886385021539
Combination Product (Y/N)N
Initial Reporter StateTX
Initial Reporter CountryUS
PMA/510(K) Number
K931588
Number of Events Summarized1
Summary Report (Y/N)N
Reporter Type Manufacturer
Report Source health professional
Initial Reporter Occupation Physician
Type of Report Initial
Report Date (Section B) 08/24/2021
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
Operator of Device Lay User/Patient
Device Model NumberPIP-20
Device Catalogue NumberPIP20
Device Lot NumberUNKNOWN
Was Device Available for Evaluation? No
Type of Report(Section G)Initial
Initial Date Received by Manufacturer 07/29/2021
Initial Report FDA Received Date08/24/2021
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
Outcome Attributed to Adverse Event Required Intervention;
Patient Age74 YR
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