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

Model Number	N/A
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Extraskeletal ossification (1428); Pain (1994); Loss of Range of Motion (2032)
Date of Event	06/10/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).Customer has indicated that the product will not be returned to zimmer biomet for investigation, as the device remains implanted.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.Dob: (b)(6).Concomitant medical products: 42502006002, femur, lot # 63946930, 42521000410, articular surface, lot # unknown.Report source: (b)(6).Multiple mdr reports were filed for this event, please see associated reports: 3007963827 - 2020 - 00012, 0002648920 - 2020 - 00013.
Event or Problem Description
It was reported that approximately 6 months post implantation, the patient had complaints of severe pain, difficulty with adls and stiffness.At 1 year post op, heterotopic ossification was identified on an x-ray.There has been no report of any intervention.Attempts have been made and no further information has been provided.
Additional Manufacturer Narrative
(b)(4).Udi # (b)(4).No product was returned or pictures provided; visual and dimensional evaluations could not be performed.Review of the device history records identified no related deviations or anomalies.Medical records were provided and reviewed by a health care professional.Review of the available records identified the patient was experiencing pain, moderate to extreme difficulty with activity of daily living, and severe stiffness.Per the persona knee system package insert, pain and limited range of motion are known potential adverse effects of this procedure.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.

• Brand Name: TIBIA CEMENTED 5 DEGREE STEMMED RIGHT SIZE C
• 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: 9553192
• Report Number: 3007963827-2020-00011
• Device Sequence Number: 3402815
• Product Code: JWH
• UDI-Device Identifier: 00889024471023
• UDI-Public: (01)00889024471023
• 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: distributor,foreign,study
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 05/28/2020

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: 42532006402
• Device Lot Number: 64066668
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 12/16/2019
• Supplement Date Received by Manufacturer: 05/27/2020
• Initial Report FDA Received Date: 01/06/2020
• Supplement Report FDA Received Date: 05/28/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: ITEM 4252100410 LOT 63793861; SEE H10
• Outcome Attributed to Adverse Event: Other
• Patient Age: 49 YR
• Patient Weight: 87