MAUDE Adverse Event Report: ZIMMER BIOMET, INC. CPS SHORT ANCHOR PLUG 12MM; PROSTHESIS, KNEE

Model Number	N/A
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	04/08/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).Concomitant medical products: 178528 - cps transverse pin - 097450, 178367 - cps sm sht spdl w pins - 905950, 178540 - cps centering sleeve - 527300, 178512 - cps nut co-cr-mo alloy - 099480, 150410 - oss tibial poly bearing - 002730, 150478 - oss poly lock pin - 772830, 150417 - oss non-mod tib plate short 67 - 761070, 178715 - cps 8.5cm seg fm oss tpr lt - 507400, 150476 - oss poly tibial bushing - 416430, 150493 - oss reinforced yoke - 666210, 150477 - oss poly femoral bushings - 915230, 150480 - oss axle - 942460.The customer has indicated that the product will not be returned to zimmer biomet for investigation, as the product was not returned by the patient.The investigation is in process.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: 0001825034-2021-01302, 0001825034-2021-01303, 0001825034-2021-01304, 0001825034-2021-01305.
Event or Problem Description
It was reported the patient underwent a revision approximately 18 months post implantation due to a broken compress.Attempts have been made and no further information has been provided.
Event or Problem Description
It was reported the patient underwent a revision approximately 18 months post implantation due to a broken anchor plug.Attempts have been made and no further information has been provided.
Additional Manufacturer Narrative
D10: 161036 - oss rs non mod plate short 63 - 728830 178527 - cps transverse pin 6pk 32mm - 658650 178364 - cps xs sht spdl w pins 800lbf - 558750 178536 - cps centering sleeve 14mm - 890390 178512 - cps nut co-cr-mo alloy - 987810 178710 - cps taper locking cap / oss sc - 209010 178711 - cps/oss 5cm tpr adapt w/oss sc - 830360 161092 - oss seg dstl fem 8.5cm rt - 761890 150410 - oss tibial poly bearing 12mm - 050920 150476 - oss poly tibial bushing - 406170 150477 - oss poly femoral bushings - 928380 150478 - oss poly lock pin - 807200 150480 - oss axle - 561280 150493 - oss reinforced yoke - 561480 150478 - oss poly lock pin - 490730 no product was returned or pictures provided; visual and dimensional evaluations could not be performed.The dhr was reviewed and no discrepancies relevant to the reported event were found.Medical records were not provided.A single x-ray from approx.2 months before the revision procedure was provided however it was not sent for further review as there was no obvious implant fracture seen on the image.No comparison images immediate post op was provided to determine if implant is slightly offset or if it was implanted that way, and no full image of implant provided.A definitive root cause cannot be determined.If any further information is found which would change or alter any conclusions or information, a supplemental report will be filed accordingly.Zimmer biomet will continue to monitor for trends.

• Brand Name: CPS SHORT ANCHOR PLUG 12MM
• Common Device Name: PROSTHESIS, KNEE
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 11750690
• Report Number: 0001825034-2021-01301
• Device Sequence Number: 11796941
• Product Code: KWA
• UDI-Device Identifier: 00880304461673
• UDI-Public: (01)00880304461673(17)271026(10)671340
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K062998
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Device Explanted Year: 2021
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: distributor,health profession
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 05/05/2021

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 Number: N/A
• Device Catalogue Number: 178554
• Device Lot Number: 917550
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 04/08/2021
• Supplement Date Received by Manufacturer: 05/04/2021
• Initial Report FDA Received Date: 04/29/2021
• Supplement Report FDA Received Date: 05/06/2021
• 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 Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: SEE H10.; SEE H10.
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Age: 15 YR