ZIMMER BIOMET, INC. 36MM A +3MM OFFSET POLY LINER; SHOULDER PROSTHESIS, REVERSE CONFIGURATION/EXTREMITIES
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Model Number 00-4349-036-03 |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problems
Pain (1994); Numbness (2415)
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Event Date 03/29/2013 |
Event Type
Injury
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Event Description
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It was reported that a patient underwent a right reverse shoulder arthroplasty.Subsequently, approximately a month and a half after the surgery the patient reported an increase of pain down their arm.The patient was diagnosed with nerve pain with numbness and prescribed a medication (lyrica 75mg).The patient is satisfied and all implant remain implanted.
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Manufacturer Narrative
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(b)(4).Multiple mdr reports were filed for this event, please see associated reports: 0001822565-2022-02636, 0001822565-2022-02638, 0001822565-2022-02676, 0001822565-2022-02677, 0001822565-2022-02678.Concomitant medical products: item#: 00434901213, 12mm a 130mm length humeral stem; lot#: 62248463.Item#: 00434903611, 36mm a glenosphere; lot#: 62234748.Item#: 00834902502, tm rvs base plt 25mm post +2; lot#: 62274777.Item#: unknown, unknown screw length 36; lot#: unknown.Item#: unknown, unknown screw length 42; lot#: unknown.Item#: unknown, unknown glenoid bone void filler- autograft (glenoid); lot#: unknown.Item#: unknown, unknown simplex cement; lot#: unknown.Customer 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.
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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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(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: 0001822565-2022-02636-1, 0001822565-2022-02638-1, 0001822565-2022-02676-1, 0001822565-2022-02677-1, 0001822565-2022-02678-1.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 provided and reviewed by a health care professional and a timeline was created.Review of the available records identified the following: (b)(6).2013; visit improving; satisfied anteroposterior & axillary images taken: no significant findings ae increase in pain due to suspected nerve pain; prescribed lyrica 75 mg.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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