ZIMMER BIOMET, INC. HUMERAL STEM 48 DEGREES 14 MM STEM DIAMETER 130 MM STEM LENGTH; PROSTHESIS, SHOULDER
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Model Number N/A |
Device Problem
Migration or Expulsion of Device (1395)
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Patient Problems
Pain (1994); Loss of Range of Motion (2032); Numbness (2415)
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Event Type
Injury
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Manufacturer Narrative
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(b)(4).Concomitant medical product: unknown, unknown head, unknown.Customer has been indicated that the product will not be returned to zimmer biomet for investigation.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.Multiple mdr reports were filed for this event, please see associated reports: 0001822565 - 2017 - 07262.
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Event Description
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It was reported that the patient underwent a right shoulder arthroplasty procedure.Subsequently, the patient is experiencing tightness around the humeral head, looseness around the humeral stem, limited range of motion, numbness, and some degree of pain.It was reported the humeral head was too tight and that the ball of the shoulder was too big.The bone scan was inconclusive.Attempts have been made and additional information on the reported event is unavailable.
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Manufacturer Narrative
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The following report is being submitted to report additional information.
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Manufacturer Narrative
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Concomitant medical products: trabecular metalâ¿¢ glenoid component 52 mm articular surface cat: 00432605200 lot: 62724270, offset modular humeral head 23 mm head height 52 mm spherical head diameter cat: 00430205223 lot: 62621939.Reported event was unable to be confirmed due to limited information received from the customer.Device history record was reviewed and no discrepancies relevant to the reported event were found.Review of the complaint history determined that no further action is required as no trends were identified.Root cause was unable to be determined as the necessary information to adequately investigate the reported event was not provided.Root cause was unable to be determined as the necessary information to adequately investigate the reported event was not provided.
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Manufacturer Narrative
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Udi: (b)(4).
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Search Alerts/Recalls
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