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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ZIMMER BIOMET, INC. CPS SM SPDL WITH PINS 400LBF; PROSTHESIS, KNEE
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ZIMMER BIOMET, INC. CPS SM SPDL WITH PINS 400LBF; PROSTHESIS, KNEE Back to Search Results
Model Number N/A
Medical Device Problem Code Fracture (1260)
Health Effect - Clinical Code No Code Available (3191)
Date of Event 01/29/2021
Type of Reportable Event Serious Injury
Additional Manufacturer Narrative
(b)(4).Concomitant medical devices: item 178406 lot 445710; item 178716 lot 528700; item 178540 lot 487990; item 178527 lot 730840; item 178512 lot 025940.Foreign (b)(6).Customer has indicated that the product is in process of being returned to zimmer biomet for investigation.Once the investigation has been completed, a follow-up mdr will be submitted.Multiple mdr reports were filed for this event, please see associated reports: 0001825034-2021-00349.
 
Event or Problem Description
It was reported that the patient had a total knee arthroplasty and four months after the procedure subsequently was revised due to implant fracture.Attempts have been made and no further information has been provided.
 
Additional Manufacturer Narrative
Upon reassessment of the reported event, it was determined to be not reportable.The initial report was forwarded in error and should be voided.
 
Event or Problem Description
Upon reassessment of the reported event, it was determined to be not reportable.The initial report was forwarded in error and should be voided.
 
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Brand Name
CPS SM SPDL WITH PINS 400LBF
Common Device Name
PROSTHESIS, KNEE
Manufacturer (Section D)
ZIMMER BIOMET, INC.
56 e. bell drive
warsaw IN 46582
MDR Report Key11294190
Report Number0001825034-2021-00350
Device Sequence Number14338477
Product Code KWA
UDI-Device Identifier00880304509054
UDI-Public(01)00880304509054(17)300403(10)235640
Combination Product (Y/N)N
Initial Reporter CountrySP
PMA/510(K) Number
K101475
Number of Events Summarized1
Summary Report (Y/N)N
Device Implanted Year2020
Device Explanted Year2021
Serviced by Third Party (Y/N)Unknown
Reporter Type Manufacturer
Report Source company representative,distri
Initial Reporter Occupation Physician
Type of Report Initial,Followup
Report Date (Section B) 04/20/2021
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 Health Professional
Device Model NumberN/A
Device Catalogue Number178353
Device Lot Number235640
Was Device Available for Evaluation? No
Was the Report Sent to FDA? No
Initial Date Received by Manufacturer 01/29/2021
Supplement Date Received by Manufacturer04/14/2021
Initial Report FDA Received Date02/08/2021
Supplement Report FDA Received Date04/20/2021
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
If action reported to FDA under 21 USC 360i(g), list
FDA-assigned Recall Number or include a statement		N/A
Patient Sequence Number1
Outcome Attributed to Adverse Event Hospitalization; Required Intervention;
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