MAUDE Adverse Event Report: ZIMMER ORTHOPAEDIC MFG. LTD. TIBIA CEMENTED 5 DEGREE STEMMED LEFT SIZE G; PROSTHESIS, KNEE

Model Number	N/A
Medical Device Problem Codes	Loss of or Failure to Bond (1068); Loosening of Implant Not Related to Bone-Ingrowth (4002)
Health Effect - Clinical Codes	Erosion (1750); Failure of Implant (1924); Pain (1994); Loss of Range of Motion (2032); Scar Tissue (2060); Skin Burning Sensation (4540)
Date of Event	03/10/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).Multiple mdr reports were filed for this event, please see associated report: 0001822565-2021-01323.Device explanted sometime in (b)(6) of 2020.Concomitant medical product: zimmer cat#42512600918 articular surface fixed bearing constrained posterior stabilized (cps) left 18 mm height use with tibia sizes g-h / ps femur sizes 6-9 lot#62736936.Customer has indicated that the product will not be returned to zimmer biomet for investigation.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.
Event or Problem Description
It was reported that a patient was revised approximately ten months¿ post implantation due to pain and loosening.Within months of initial surgery, the patient began to complain of being unable to straighten his leg and was experiencing extreme pain.Mechanical loosening of internal left knee prosthetic joint was noted and, at the revision, it was discovered that the implant was not seated properly and was loose and grinding on the bone.The patient believes that the implant may be subject to a recall but has been unable to confirm.There is no additional information available.
Additional Manufacturer Narrative
This follow-up is being submitted to relay additional information.No product was returned or pictures provided; therefore, visual and dimensional evaluations could not be performed.Medical records were not provided.Device history record (dhr) was reviewed for deviations and/ or anomalies with no related deviations/anomalies identified.A definitive root cause cannot be determined.If any further information is found which would change or alter any conclusions or information, a supplemental 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.
Additional Manufacturer Narrative
This follow-up is being submitted to relay additional information.Updated: a1, a2, a4, a5, b4, b5, d6, d10, g3, g6, h1, h2, h6, and h10.
Event or Problem Description
It was reported that a patient was revised approximately ten and a half months post implantation due to loosening, pain, noise, burning sensation, and limited rom.During the revision the surgeon noted the implant was not in correct position, confirmed loosening of tibia, and noted that tibial implant was grinding on the surrounding bone.
Event or Problem Description
No further event information available at the time of this report.
Additional Manufacturer Narrative
This follow-up is being submitted to relay additional information.Updated: b4, b5, g3, g6, h1, h2, h3, h6, and h10 medical records/radiographs were provided and reviewed by a health care professional.Review of the available records identified that there is no intra-op complication during the first revision surgery.Ten days post op, the patient experienced pain and bleeding.Medication was prescribed for it.X-ray noted that the implants were intact with joint effusion.The patient again presented with pain and loosening; instability was noted.Ct report states "postsurgical changes apparently from tibial osteotomy with a non-healed bony fragment that has sclerotic type rim margins along the upper portion of the proximal tibia over about 2.25 cm in height.Below this there is partial incorporation of a bony flap/bony density along the anterior tibial cortex with persistent non healed portion along the lower aspect over about 3 cm in height also with some developing sclerosis around portions of the margins in this area.Between these two areas there is partial incorporation of bone along the anterior tibia around the middle cerclage wire that is present".Office visits show the patient had rom 5-90 with pain with severe burning sensation, no swelling.The patient underwent revision surgery for mechanical loosening.During the revision, surgeon states " implant from 1st revision not seated properly, loose, and was "grinding" on the bone around the implant site".No op records were provided.A definitive root cause cannot be determined.If any further information is which would change or alter any conclusions or information, a supplemental will be filed accordingly.Zimmer biomet will continue to monitor for trends.
Event or Problem Description
It was reported that a patient was revised approximately ten months post implantation due to loosening, pain, noise, burning sensation, instability, and limited rom.During the second revision the surgeon noted scar tissue and the implant was not in correct position, confirmed loosening of tibia, and tibial implant was grinding on surrounding bone.The tibia, femur, and articulating surface were exchanged, and the cerclage cables were removed without complications.The patella was well fixed and remained implanted.Attempts to obtain additional information have been made; however, no more information is available.
Additional Manufacturer Narrative
This follow-up is being submitted to relay additional information.D10-medical product articular surface fixed bearing (cps) left 18 mm height item# 42512600918, lot# 62736936.Femur cemented (ps) standard left size 9 item# 42500606601, lot# 63526570.Stem extension tapered cemented 14 mm diameter +30 mm length item# 42557000114, lot# 64288130.3 unknown cerclage wires.
Additional Manufacturer Narrative
This follow-up is being submitted to relay additional information.Review of the device history record(s) identified no deviations or anomalies during manufacturing.Operative notes were provided, and review found patient experienced pain, instability and implant loosening.No sign of inflammation and infection.Tibia was loose and femur was removed with minimum bone loss.Scar tissue was debrided.No complication was noted and found all implants except patella was revised.No change in the root cause.If any further information is received which would change or alter any conclusions or information, a supplemental 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.

• Brand Name: TIBIA CEMENTED 5 DEGREE STEMMED LEFT SIZE G
• Common Device Name: PROSTHESIS, KNEE
• Manufacturer (Section D): ZIMMER ORTHOPAEDIC MFG. LTD.; building no 2 east park; shannon industrial estate; shannon, county clare ; EI
• Manufacturer (Section G): ZIMMER ORTHOPAEDIC MFG. LTD.; building no 2 east park; shannon industrial estate; shannon, county clare ; EI
• Manufacturer Contact: christina arnt ; 56 e. bell dr.; warsaw, IN 46582 ; 5745273773
• MDR Report Key: 11831307
• Report Number: 3007963827-2021-00105
• Device Sequence Number: 845679
• Product Code: MBH
• UDI-Device Identifier: 00889024471092
• UDI-Public: (01)00889024471092(17)280731(10)64072967
• Combination Product (Y/N): N
• Initial Reporter State: IN
• Initial Reporter Country: US
• PMA/510(K) Number: K172524
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Device Explanted Year: 2020
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Consumer,Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date (Section B): 09/12/2023

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: 42532007901
• Device Lot Number: 64072967
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 04/22/2021
• Supplement Date Received by Manufacturer: 06/07/2021; 08/18/2022; 01/06/2023; 03/14/2023; 09/07/2023
• Initial Report FDA Received Date: 05/17/2021
• Supplement Report FDA Received Date: 06/08/2021; 09/13/2022; 01/10/2023; 04/05/2023; 09/12/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 08/09/2018
• 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
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Age: 43 YR
• Patient Sex: Male
• Patient Weight: 96 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: Black Or African American