MAUDE Adverse Event Report: ZIMMER BIOMET, INC. CPS SHORT ANCHOR PLUG 10MM; PROSTHESIS, KNEE

Model Number	N/A
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Codes	Failure of Implant (1924); Pain (1994); Ambulation or Postural Difficulties (2544)
Date of Event	01/31/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).Concomitant medical products: 178527 cps transverse pin 6pk 32mm m - 297750, 178526 cps transverse pin 6pk 28mm m - 803450, 178512 cps nut co-cr-mo alloy 913320, 178710 cps taper locking cap / oss sc rew 361860, 178711 cps/oss 5cm tpr adapt w/oss sc 5cm 490430, 161012 oss rs 7 cm mod seg fmrl-lt lt 271580, 150468 oss rs poly fem bushings set/2 223620, 150493 oss reinforced yoke 103130, 150476 oss poly tibial bushing 194630, 161035 oss rs axle 344400, 161094 oss rs 12mm ls tibial bearing 622880, 150478 oss poly lock pin -634510.Report source 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.
Event or Problem Description
It was reported that the patient had an oss compress implanted 7 months ago.Subsequently, the patient was revised due to a broken compress part.Attempts have been made and no further information has been provided.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional information.Visual inspection of returned device was found to exhibit damage nicked, gouged and the shaft is fractured off.Additional testing of the product states that fracture is due to fatigue.Further elemental analysis of the cps short anchor plug sample showed that it was conforming.The device history record was reviewed and no discrepancies relevant to the reported event were found.Surgical notes provided confirm that patient underwent revision surgery due to pain and failed oss compress distal femoral prosthesis left/ reconversion oss total femur prosthesis.X-ray review by mmi confirms implant fracture and states that there is disruption of the oss device at the proximal femoral junction with marked varus angulation of the femur.Bone quality is osteopenic.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.
Event or Problem Description
No further event information available at the time of this report.
Event or Problem Description
No further event information available at the time of this report.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional information.The following sections were updated: b4; b5; d1; d2; d4; d9; d10; g3; g4; g6; h1; h2; h3; h4 d10: 178363 - cps xs sht spdl w pins 600lbf - 204870 product has been received by zimmer biomet and the investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.
Event or Problem Description
No further event information available at the time of this report.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional information.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.

• Brand Name: CPS SHORT ANCHOR PLUG 10MM
• Common Device Name: PROSTHESIS, KNEE
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• Manufacturer (Section G): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• Manufacturer Contact: christina arnt ; 56 e. bell dr.; warsaw, IN 46582 ; 5745273773
• MDR Report Key: 13483106
• Report Number: 0001825034-2022-00282
• Device Sequence Number: 17279140
• Product Code: KWA
• UDI-Device Identifier: 00880304508927
• UDI-Public: (01)00880304508927(17)300205(10)204870
• Combination Product (Y/N): N
• Initial Reporter Country: BE
• PMA/510(K) Number: K062998
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Device Explanted Year: 2022
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 06/07/2022
• 2 Devices were Involved in the Event: 1 2

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: 178552
• Device Lot Number: 467170
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/07/2022
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/31/2022
• Supplement Date Received by Manufacturer: 02/08/2022; 03/10/2022; 06/07/2022
• Initial Report FDA Received Date: 02/08/2022
• Supplement Report FDA Received Date: 02/24/2022; 03/11/2022; 06/08/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/11/2020
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• 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 Sex: Prefer Not To Disclose