ZIMMER BIOMET, INC. ARTICULAR SURFACE WITH SEGMENTAL HINGE POST SIZE B 12 MM HEIGHT; PROSTHESIS, KNEE
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Model Number N/A |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problem
Bacterial Infection (1735)
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Event Date 01/25/2019 |
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: 0001822565-2019-00730, 0001822565-2019-00731, 0001822565-2019-00732, 0001822565-2019-00733, 0001822565-2019-00734, and 0001822565-2019-00735.Concomitant medical devices: distal femoral xt component size b right, catalog#: 00585004202, lot#: ni; segment with male/female taper 140 mm length, catalog#: 00585004614, lot#: ni; segment with male/female taper 30 mm length, catalog#: 00585004603, lot#: ni; tibial component precoat size 4, catalog#: 00588000400, lot#: ni; stem extension straight 18mm dia x 100mm length, catalog#: 00598801018, lot#: ni.Report source: (b)(6).Customer has indicated that the product will not be returned to zimmer biomet for investigation, as the hospital would not release the devices.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 patient underwent right knee arthroplasty.Subsequently, patient underwent irrigation, debridement, and replacement of components due to suspected infection and tibial loosening.
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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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This follow-up report is being submitted to relay additional information.The following sections were updated: date of report, date received by mfr, type of report, follow up type, evaluation codes, additional narrative.The product could not be evaluated and the reported event was not confirmed.The device history records could not be reviewed as the lot number associated with the reported event is unknown.Single-use, sterilized devices manufactured or distributed by zimmer are sterilized in accordance with fda regulations and iso standards to a sterility assurance level of 1.0 x 10-6 or better.Therefore, it is highly unlikely that the specified device caused any patient infection.However, a definitive root cause could not 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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