Model Number N/A |
Device Problem
Unstable (1667)
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Patient Problems
Pain (1994); Tissue Damage (2104); Limited Mobility Of The Implanted Joint (2671)
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Event Date 08/13/2018 |
Event Type
Injury
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Manufacturer Narrative
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(b)(4).Concomitant medical products: 00430204652 glenoid component pegged 52 mm diameter articular surface used with white (46 mm) instruments 62890682, 00434211313 humeral stem 42 degrees 13 mm stem diameter 130 mm stem length 62357351.The complaint is under investigation.Once the investigation is complete a follow up report will be submitted.Multiple mdr reports were filed for this event, please see associated reports: 0001822565 - 2019 - 01265, 0001822565 - 2019 - 01266.
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Event Description
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It was reported that the patient underwent an initial left shoulder arthroplasty.The patient began experiencing limited range of motion/strength, a grinding sensation, and increased pain in the shoulder shortly following the initial procedure.The patient was subsequently revised approximately seventeen (17) months post primary implantation due to pain, tendon tear and lucency.No additional information is available.
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Manufacturer Narrative
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The complaint is under investigation.Once the investigation is complete a follow up report will be submitted.
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Event Description
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It was reported that the patient underwent an initial left shoulder arthroplasty.The patient began experiencing limited range of motion/strength, a grinding sensation, and increased pain in the shoulder shortly following the initial procedure.The patient was subsequently revised approximately seventeen (17) months post primary implantation due to pain, tendon tear and instability.No additional information is available.
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Event Description
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No further event information available at the time of this report.
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Manufacturer Narrative
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Review of the device history record(s) identified no deviations or anomalies during manufacturing.The reported products were reviewed for compatibility with no issues noted.Review of complaint history found no additional related issues for this/these item(s) and the reported part and lot combination(s).Medical records were provided and review of the available records identified the following: no intraoperative complications noted during initial surgery and "significant scarring of the subacromial space with the subscap and deltoid adhered to the proximal humerus¿small full-thickness supraspinatus tendon tear.Minimal bone loss proximal humerus.Posterior rotator cuff was intact." was noted on revision op-notes.Reported event was confirmed by review of medical records.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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Search Alerts/Recalls
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