ZIMMER SWITZERLAND MANUFACTURING GMBH ANATOMICAL SHOULDER REVERSE, SCREW SYSTEM, 4.5-36; ZIMMER TRABECULAR METAL REVERSE SHOULDER SYSTEM
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Model Number N/A |
Device Problems
Fracture (1260); Material Integrity Problem (2978); Patient Device Interaction Problem (4001); Loosening of Implant Not Related to Bone-Ingrowth (4002)
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Patient Problems
Failure of Implant (1924); Pain (1994)
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Event Date 04/06/2021 |
Event Type
Injury
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Manufacturer Narrative
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Concomitant medical products: anatomical shoulder reverse screw system 4.5-42, catalog#: 01.04223.042, lot#: 2985867; base plate 25 mm post length +2 mm lateral offset uncemented, catalog#: 00-4349-025-02, lot#: 64351007; glenosphere 36 mm diameter, catalog#: 00-4349-036-11, lot#: 64367752; anatomical shoulder reverse humeral cup retro +6 mm medial offset, catalog#: 01.04223.106, lot#: 3004536; anatomical shoulder reverse humeral insert pe 36-3, catalog#: 01.04223.363, lot#: 3006738.Therapy date: (b)(6) 2021.The manufacturer did receive x-rays for review.Other documents were received and will be reviewed as part of ongoing investigation.The manufacturer did not receive the device for investigation.Where lot numbers were received for the devices, the device history records were reviewed and found to be conforming.A cause for this specific event cannot be ascertained from the information provided.As soon as supplemental information becomes available an updated report will be submitted.Zimmer biomet¿s reference number of this file is (b)(4).
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Event Description
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Patient was implanted on the right side and underwent revision surgery due to pain, loosening and implant fracture.
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Event Description
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Patient was implanted on the right side and underwent revision surgery due to pain, loosening and implant fracture.
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Manufacturer Narrative
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D10: medical products: anatomical shoulder reverse, screw system, 4.5-42; catalog#: 01.04223.042; lot#: 2985867 base plate 25 mm post length +2 mm lateral offset uncemented; catalog#: 00-4349-025-02; lot#: 64351007; glenosphere 36 mm diameter; catalog#: 00-4349-036-11; lot#: 64367752; anatomical shoulder reverse, humeral cup, retro, +6 mm medial offset; catalog#: 01.04223.106; lot#: 3004536; anatomical shoulder reverse, humeral insert, pe, 36-3; catalog#: 01.04223.363; lot#: 3006738 anatomical shoulder, humeral stem, uncemented, 14, 100 mm; catalog#: 01.04201.143; lot#: 2996924.Therapy date: on (b)(6) 2021.This follow-up report is being filled to relay additional information, which was unknown at the time of the previous medwatch.Additional information was received on apr 14, 2021.The manufacturer received other source documents for review.Should additional information become available and / or the device(s) be returned for evaluation and an investigation result be available, that changes this assessment, an amended medical device report will be submitted.Zimmer¿s reference number of this file is (b)(4).
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Manufacturer Narrative
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This follow-up report is being submitted to relay corrected and additional information.Additional: h2, h6.Correction: b4, g3, g6, h10.Event description: it was reported that the patient received the implant on (b)(6) 2019 and the patient started experiencing pain post implantation.After preliminary examination on (b)(6) 2021 by dr.(b)(6), it was reported that the tm glenoid baseplate was loosened along with screw fracture.It was also reported that patient underwent revision surgery on (b)(6), 2021 due to pain, loosening and implant fracture.Review of received data: due diligence: no further due diligence required as all required information to support the conclusion is available or was already requested.X-rays: the x-ray review shows an abnormally angulated glenoid fixation screw that appears fractured.Overall alighnment is maintained.There is a small amount of lucency at the osseous margin of the glenoid baseplate.Bone quality is osteopenic.Product evaluation: no product was returned; therefore, visual and dimensional evaluation could not be performed.Review of product documentation: device purpose: all involved devices are intended for treatment.Product compatibility: the product combination was approved by zimmer biomet.Dhr review: review of the device history records identified no deviations or anomalies during manufacturing.Ncr(s): no ncr with a potential correlation to the reported event was found.Conclusion: it was reported that the patient received the implant on (b)(6) 2019 and the patient started experiencing pain post implantation.After preliminary examination on (b)(6) 2021 by dr.(b)(6), it was reported that the tm glenoid baseplate was loosened along with screw fracture,it was also reported that.Patient underwent revision surgery on (b)(6) 2021 due to pain, loosening and implant fracture.Based on the investigation the reported event can be confirmed for one screw.However, it is unknown which screw is the one that fractured.The quality records show that all specified characteristics have met the specifications valid at the time of production.Therefore, the investigation did not identify a nonconformance or a complaint out of box (coob).Based on the given information and the results of the investigation, we were not able to identify a specific root cause for this issue.The need for corrective measures is not indicated and zimmer switzerland manufacturing gmbh considers this case as closed.Zimmer biomet¿s reference number of this file is (b)(6).
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Event Description
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No change to previously reported event.
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