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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: STRYKER GMBH 10 SILICONE PIP IMPLANT (STERILE PACKED); PROSTHESIS, FINGER, CONSTRAINED, POLYMER

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STRYKER GMBH 10 SILICONE PIP IMPLANT (STERILE PACKED); PROSTHESIS, FINGER, CONSTRAINED, POLYMER Back to Search Results
Model Number PIP-10
Device Problem Device Dislodged or Dislocated (2923)
Patient Problem Joint Dislocation (2374)
Event Date 12/14/2021
Event Type  Injury  
Event Description
As reported: "woman dislocated finger between 2-6 weeks post op.No problem with implant." revision surgery performed.
 
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.
 
Manufacturer Narrative
The reported event 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 such as some patient info (activity levels), x-rays, implantation date, 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.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
As reported: "woman dislocated finger between 2-6 weeks post op.No problem with implant." revision surgery performed.
 
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Brand Name
10 SILICONE PIP IMPLANT (STERILE PACKED)
Type of Device
PROSTHESIS, FINGER, CONSTRAINED, POLYMER
Manufacturer (Section D)
STRYKER GMBH
bohnackerweg 1
postfach
selzach 2545
SZ  2545
Manufacturer (Section G)
STRYKER GMBH
bohnackerweg 1
postfach
selzach 2545
SZ   2545
Manufacturer Contact
anna jusinski
325 corporate drive
mahwah, NJ 07430
2018315000
MDR Report Key13582003
MDR Text Key286774526
Report Number0008031020-2022-00069
Device Sequence Number1
Product Code KYJ
UDI-Device Identifier00886385021515
UDI-Public00886385021515
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K931588
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Health Professional
Reporter Occupation Physician
Type of Report Initial,Followup
Report Date 05/09/2022
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? No
Device Operator Lay User/Patient
Device Model NumberPIP-10
Device Catalogue NumberPIP10
Device Lot Number14651G
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 01/26/2022
Initial Date FDA Received02/22/2022
Supplement Dates Manufacturer Received04/12/2022
Supplement Dates FDA Received05/09/2022
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured10/15/2020
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
Patient Outcome(s) Required Intervention;
Patient SexFemale
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