MAUDE Adverse Event Report: ZIMMER ORTHOPAEDIC MFG. LTD. ARTICULAR SURFACE FIXED BEARING (PS) LEFT 13 MM HEIGHT; PROSTHESIS, KNEE

Model Number N/A

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Tissue Damage (2104)

Event Type  Injury  

Manufacturer Narrative

(b)(4).Multiple mdr reports were filed for this event, please see associated reports: 3007963827-2020-00238, 0001822565-2020-03346, and 0002648920-2020-00430.Concomitant medical devices: femur cemented posterior stabilized (ps) narrow left size 8 catalog#: 42500006401 lot#: 64558631, natural tibia trabecular metal two-peg porous fixed bearing left size d catalog#: 42530006701 lot#: 64678941, all poly patella cemented 32 mm diameter catalog#: 42540000032 lot#: 64620936.Customer has indicated that the product will not be returned to zimmer biomet for investigation, as it remains implanted.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.

Event Description

It was reported that patient developed an allergic reaction and blisters on the surgical site subsequent to bilateral total knee arthroplasty.Topical medications were prescribed.No revision has been reported.

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.Reported event was confirmed by review of medical records.Review of the available records identified the following: three weeks after implantation: allergic reaction at knee resulting in rash and blisters, topical otc benedryl and hydrocortisone prescribed, outcome pending.Six week visit ¿ normal alignment and stability.Rom 100.6-10 degrees flexion contracture.Moderate pain.Normal radiographic findings.Two month office visit ¿ overall, patient reports her pain is improving, has less stiffness, and is pleased with her progress.Ambulating with appropriate gait with cane and walker.The incision is well healed and intact.Rom 3-115.The knee is stable with no laxity noted with valgus or varus stressing.Quadriceps strength 5/5.Neurovascularly intact.No x-rays on the visit.Previous x-rays have shown a well-positioned, stable arthroplasty.Surgeon¿s recommendations ¿ d/c formal therapy.Transition from cane/walker to cane only.Released to drive.F/u one month with plan to return to work.Device history record was reviewed and no discrepancies were found.The allergic reaction was most likely caused by the patient's allergies to wellbutrin, latex, and pcn since it was treated with otc meds; however it cannot be confirmed with the information available.Therefore, 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 Description

It was reported that patient developed an allergic reaction and blisters on the surgical site subsequent to bilateral total knee arthroplasty.Topical medications were prescribed.Outcome has since resolved.Attempts to obtain additional information have been made; however, no more is available.

• Brand Name: ARTICULAR SURFACE FIXED BEARING (PS) LEFT 13 MM HEIGHT
• Type of Device: PROSTHESIS, KNEE
• Manufacturer (Section D): ZIMMER ORTHOPAEDIC MFG. LTD.; building no 2 east park; shannon industrial estate; shannon, county clare ; EI
• MDR Report Key: 10592511
• MDR Text Key: 208721342
• Report Number: 3007963827-2020-00239
• Device Sequence Number: 1
• Product Code: JWH
• Combination Product (y/n): N
• PMA/PMN Number: K113369
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,study
• Type of Report: Initial,Followup
• Report Date: 01/04/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/28/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: 42511400513
• Device Lot Number: 64444409
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 12/10/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Treatment: SEE H10
• Patient Outcome(s): Required Intervention
• Patient Weight: 80