ZIMMER BIOMET, INC. EXPLOR 8X28MM IMPL STEM W/SCR; PROSTHESIS, ELBOW, HEMI-, RADIAL, POLYMER
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Catalog Number 11-210063 |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problems
Ossification (1428); Pain (1994); Loss of Range of Motion (2032); Scar Tissue (2060); Discomfort (2330)
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Event Date 04/28/2021 |
Event Type
Injury
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Manufacturer Narrative
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(b)(4).Reporter has indicated that the product will not be returned to zimmer biomet for investigation, as the product remains implanted.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.Zimmer biomet will continue to monitor for trends.Associated products and reports.0001825034-2023-01077.Item#11-210034; lot#238890.
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Event Description
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It was reported a patient underwent a left elbow procedure.Subsequently, the patient developed moderate stiffness and limited extension.The patient required reoperation to excise thick scar tissue on the anterior aspect of the joint and ossification excision was also performed.The patient has continued to experience mild pain for which additional consultation is ongoing.However, components remain in place.Attempts have been made and no further information has been provided.
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Event Description
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No further event information is available at the time of this report.
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Manufacturer Narrative
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This follow-up report is being submitted to relay additional information.H6: proposed annex g 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.Medical records were provided and reviewed by a health care professional and a timeline was created.Review of the available records identified the following: initial surgery: l primary radial head arthroplasty procedure, no complications noted, patient tolerated the procedure well and left the or in stable condition.3 months postop; onset of moderate stiffness in the l elbow with limited extension noted.4 months post op; reoperation of affected joint, scar tissue and ossification excised.14 months postop: mild pain noted, injection given, patient remains in study 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.
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