It was reported a patient had a right total hip arthroplasty.Subsequently, the patient was revised approximately 13 years later.During the revision, the surgeon found non-union of the trochanter.The revision was completed without complication.It was reported that no further information is available.
|
(b)(4).D10: cat# 00877503204, lot# 2724106 biolox⮠delta, ceramic femoral head, xl, 㸠32/+7, taper 12/14.Cat# 00630504832 lot# 65039055 liner standard 32 mm i.D.For use with 48 mm o.D.Shell.Cat# 00620204822 lot# 07876013 shell porous with cluster holes 48 mm.Cat#47249009700, lot# 65537328 tear drop guide wire 3.0 mm diameter 100 cm length.Cat# 0100101914, lot# 3011183 wagner sl revision⮠hip stem, uncemented, 㸠14/190, taper 12/14.Cat# 00223200206, lot# 56694392 extended 4 hole gtr w/4 cables.The customer has indicated that the product will not be returned to zimmer biomet for investigation as its location is unknown.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.
|
This follow-up report is being submitted to relay additional information.Component code: mechanical (g04) ¿ stem.No product was returned or pictures provided; visual and dimensional evaluations could not be performed.Review of the device history record(s) identified no deviations or anomalies during manufacturing related to the reported event.Medical records were provided and reviewed by a health care professional.Review of the available records identified the following: an initial right tha was performed.The patient began experiencing recurrent dislocations that were reduced.A second revision occurred due to instability, non-union, abductor dysfunction, and impingement.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.
|