MAUDE Adverse Event Report: ZIMMER ORTHOPAEDIC MFG. LTD. FEMUR CEMENTED CRUCIATE RETAINING (CR) STANDARD LEFT SIZE 6; PROSTHESIS, KNEE

Model Number	N/A
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Muscular Rigidity (1968); Pain (1994); Loss of Range of Motion (2032); Swelling (2091); Limited Mobility Of The Implanted Joint (2671)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).Multiple mdr reports were filed for this event, please see associated report: 3007963827-2020-00281, 0001822565-2020-03649.Dob: (b)(6).Concomitant medical products: tibia cemented 5 degree stemmed left size c, item# 42532006401, lot# 63783320.Articular surface fixed bearing cruciate retaining (cr) left 10 mm height, item# 42511000410, lot# 63596762.Report source: (b)(6).Customer has indicated that the product will not be returned to zimmer biomet for investigation because it remains implanted.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 experienced pain, swelling, stiffness and decreased range of motion which required medication approximately two years post-implantation.There is no additional information at this time.
Event or Problem Description
No further event information available at the time of this report.
Additional Manufacturer Narrative
No product was returned or pictures provided; therefore, visual and dimensional evaluations could not be performed.Polar study report was provided and reviewed by a health care professional.Review of the available records identified the following: patient experienced severe pain in the medial joint line, lateral joint line and infrapatellar region for more than two years and indicated that the patient was administered pain killers.Stiffness with rom of 85-90 was noted during this two years and occasional swelling was noted too.Device history record (dhr) was reviewed for deviations and/ or anomalies with no deviations / anomalies identified.A definitive root cause cannot be determined.Per package insert 87-6204-022-23 rev a: pain, swelling and poor range of motion is known adverse effect of the system.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.

• Brand Name: FEMUR CEMENTED CRUCIATE RETAINING (CR) STANDARD LEFT SIZE 6
• Common Device Name: PROSTHESIS, KNEE
• Manufacturer (Section D): ZIMMER ORTHOPAEDIC MFG. LTD.; building no 2 east park; shannon industrial estate; shannon, county clare ; EI
• MDR Report Key: 10752899
• Report Number: 3007963827-2020-00280
• Device Sequence Number: 17015715
• Product Code: JWH
• UDI-Device Identifier: 00889024230330
• UDI-Public: (01)00889024230330
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: K113369
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 01/21/2021

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?: No
• Operator of Device: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: 42502606001
• Device Lot Number: 63605407
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 10/19/2020
• Supplement Date Received by Manufacturer: 01/20/2021
• Initial Report FDA Received Date: 10/28/2020
• Supplement Report FDA Received Date: 01/21/2021
• 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
• Outcome Attributed to Adverse Event: Other
• Patient Weight: 98