|
Model Number N/A |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
|
Patient Problems
Adhesion(s) (1695); Loss of Range of Motion (2032)
|
Event Date 04/29/2019 |
Event Type
Injury
|
Manufacturer Narrative
|
(b)(4).Multiple mdr reports were filed for this event, please see associated reports: 3007963827-2020-00085, 3007963827-2020-00086, and 0002648920-2020-00179.Concomitant medical products: femur cemented cruciate retaining (cr) narrow left size 6 catalog#: 42502006001 lot#: 64116798, articular surface medial congruent (mc) left 10 mm height catalog#: 42512100410 lot#: 64164251, natural tibia trabecular metal two-peg porous fixed bearing left size d catalog#: 42530006701 lot#: 64050819.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 underwent a left total knee arthroplasty.Subsequently, she had a closed manipulation at approximately 4 weeks postop and a closed manipulation under anesthesia (mua) approximately three months later, with hospital admission for aggressive pt and continuous cpm due to ongoing postoperative arthrofibrosis and limited rom.The outcome remains pending.
|
|
Manufacturer Narrative
|
This follow-up is being submitted to relay additional information.Updated: b4, b5, d4, g4, g7, h1, h2, h3, h6, and h10.No product was returned or pictures provided; therefore, visual and dimensional evaluations could not be performed.Medical records were provided and reviewed by a health care professional.Review of the available records identified the following: at six-month post op patient had flexion 94/extension 6 and underwent closed manipulation.Radiographs show no evidence of gaps between bone/ implant interface.Approximately four months¿ post op patient had range of motion from 12-56 and underwent mua.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 Description
|
No further event information available at the time of this report.
|
|
Search Alerts/Recalls
|
|
|