ZIMMER BIOMET, INC. 4 PEG MOD GLEN LT AUG SZ 4; PROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER CEMENTED/EXTREMITIES
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Model Number SAGL2144 |
Device Problem
Positioning Problem (3009)
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Patient Problem
Muscle/Tendon Damage (4532)
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Event Date 09/30/2022 |
Event Type
Injury
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Manufacturer Narrative
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(b)(4).Multiple mdr reports were filed for this event, please see associated reports: product previously reported under mfr number 0001825034-2022-02496.Concomitant medical products: item#: sagp0002, modular post tm; lot#: 65114001; item#: 118001, versa-dial/comp ti std taper; lot#: 230290; item#: 113032, versa-dial 42x18x46 hum head; lot#: 807290.Customer has indicated that the product will not be returned to zimmer biomet for investigation, as the product location is unknown.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.
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Event Description
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It was reported that the patient underwent a revision surgery due to malposition of the implant and failure of the patient's rotator cuff muscle.
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Manufacturer Narrative
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(b)(4).This follow-up report is being submitted to relay additional information.Multiple mdr reports were filed for this event, please see associated reports: 0001822565-2022-03396-1.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 not provided.It is alleged that the glenoid products moved position over time.However, without medical records this cannot be confirmed.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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Event Description
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No further event information available at the time of this report.
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