MAUDE Adverse Event Report: ZIMMER, INC. PERSONA ARTICULAR SURFACE; MBH

Model Number N/A

Device Problem Pitted (1460)

Patient Problem Pain (1994)

Event Date 03/24/2016

Event Type  Injury  

Manufacturer Narrative

This report will be amended when our investigation is complete.

Event Description

It is reported that the patient was revised due to pain.Upon revision, the articular surface was found to be damaged.

Manufacturer Narrative

Concomitant products: persona ps femoral, narrow, size 10, left catalog #:42-5000-068-01 lot #:62770217.Persona stemmed 5 degree tibia, size f, left catalog #:42-5320-075-01 lot #:62779018.Persona all-poly patella, 32mm x 8.5mm catalog #:42-5400-000-32 lot #:62859185.This follow-up report is being filed to relay additional information, which was unknown at the time of the initial medwatch.This is report 1 of 3 for (b)(4) - see also 3007963827-2016-00070-1 and 0002648920-2016-03243-1.No product was returned.Visual evaluation of photographs of the removed articular surface found that the device was discolored with pitting all over the condylar surfaces.The lateral edges at the top of the post looked worn and altered as if they had crept slightly.The most-lateral region of the medial condylar surface showed antero-posterior scratch lines and there was a gouge on the anterior edge.The device history records for the 42-5126-008-10, lot #62852142, were reviewed for deviations and/ or anomalies with no deviations/ anomalies identified.The device history records for the 42-5320-075-01, lot # 62779018 were reviewed and a non-conformance was identified during the implementation of the plastic plugs on the products.The machine failed the microbiology test so the products were placed on hold.The investigation determined that the issue had no impact on the products as they were processed through upgrade operation and gamma sterilization that provide a sterility assurance level of 10-6.This non-conformance could not have contributed to the reported event.The device history records for the 42-5000-068-01, lot # 62770217 were reviewed and a non-conformance was identified during the final clean inspection.Defects were found on two units so the whole lot was dispositioned as standard rework followed by inspection of all the units.This standard rework did not have any adverse effect on the quality and functionality of the product, and could not have contributed to the reported event.These devices are used for treatment.A complaint history search identified no other complaint for lot #62852142, lot #62770217, lot #62779018.The primary surgical notes state that the patient underwent tka to treat progressive left knee pain, arthritis and degeneration associated with valgus deformity, lateral wear and bone loss.Soft tissues were resected or released, and osteophytes were removed.The patella and trochlea demonstrated wear.Severe end-stage articular damage with little to no remaining lateral weight bearing cartilage was found.The lateral compartment was severely eburnated with bone loss on the posterior lateral tibia and posterior lateral femoral condyles, resulting in valgus deformity.The predominant lateral wear defect necessitated asymmetric medial and lateral cut depths to achieve proper alignment.With the tibial, femoral, and patellar trial components in place, the knee achieved full extension, range of motion was excellent without instability and range of motion was excellent with no instability in valgus-varus stress and excellent patella tracking.The knee was irrigated, suctioned, and dried.The final components were cemented in place with a poly trial and the knee held in extension until the cement had cured.Excess cement was removed.The knee was taken through a range of motion and the final 10 cps articular surface replaced the trial poly.Knee stability and range of motion (0 to 135 degrees without excessive stress) were excellent with the capsule closed.No complications were noted.The revision surgical notes state that the patient underwent revision for a failed left tka due to aseptic loosening about one year post implantation.The following operative findings are reported: loose femoral and tibial components, well-fixed cemented patellar component, and osteolytic lesion in the medial tibial plateau.Intra-operatively, a significant amount of hypertrophic synovium consistent with wear debris was found.All frozen section and cultures came back negative for acute inflammation.The articular surface was noted to have thinning and delamination throughout, much more wear than expected after the short in-vivo period.Based on the reported weight and height, the patient is overweight with a bmi of 27.4.Per the package inserts of the components, pain, wear of the polyethylene articular surface, progressive osteolysis as a result of foreign-body reaction to wear debris, and loosening of the prosthetic knee components are known potential adverse effects of this tka procedure.The insert also informs that complications and/or failure of prosthetic implants are more likely to occur in heavy patients.Based on the condition of the tibia prior to the primary surgery and the bmi of the patient, the patient condition is considered to be the root cause of the issue.

• Brand Name: PERSONA ARTICULAR SURFACE
• Type of Device: MBH
• Manufacturer (Section D): ZIMMER, INC.; 1800 west center street; warsaw IN 46580
• Manufacturer (Section G): .; 1800 west center street; warsaw IN 46580
• Manufacturer Contact: carrie schneider ; p.o. box 708; warsaw, IN 46581-0708 ; 8006136131
• MDR Report Key: 5635234
• MDR Text Key: 44551386
• Report Number: 0001822565-2016-01467
• Device Sequence Number: 1
• Product Code: MBH
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: PK123459
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor
• Reporter Occupation: Medical Equipment Company Technician/Representative
• Type of Report: Initial,Followup
• Report Date: 02/15/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/05/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 10/31/2019
• Device Model Number: N/A
• Device Catalogue Number: 42512600810
• Device Lot Number: 62852142
• Other Device ID Number: N/A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 02/03/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/10/2014
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 58 YR
• Patient Weight: 87