(b)(4).Concomitant medical products: medical product: oxf anat brg rt md size 4 pma catalog #: 159576 lot #: 773900, medical product: oxf uni tib tray sz d rm pma catalog #: 154725 lot #: 556090.Multiple mdr reports were filed for this event, please see associated reports: 3002806535-2019-00941, 3002806535-2019-00943.The investigation is in process.Once the investigation is complete, a follow-up mdr will be submitted.
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(b)(4).This final report is being submitted to relay additional information.The following sections were updated: b4, b5, g4, h1, h2, h3, h6, h10 multiple mdr reports were filed for this event, please see associated reports: 3002806535-2019-00941-1, 3002806535-2019-00943-1 as the product has not been received, the investigation was limited to the information provided; a review of device history records and complaint history.Radiographs of the right knee reveal severe joint space narrowing, marginal bone spur, subchondral cyst formation, osteophyte formation.Moderate arthritis is noted in the patellofemoral compartment.Severe arthritic changes are noted in the lateral compartment.Post operative radiographs reveal good prosthesis alignment, no evidence of prosthesis loosening.The information available suggests that the oxford partial knee was well-fixed at the time of revision and functioned as intended.The manufacturing history records for the oxford partial knee tibial tray, femoral component and anatomical bearing have been checked and verify that the components were manufactured and sterilised in accordance with the applicable specifications.The surgical notes provided suggest that disease progression of osteoarthritis in the lateral compartment and patellofemoral compartment have contributed to the revision in this instance.Instability was also mentioned as a contributing factor, however the root cause of this cannot be established with the available information, but may have been related to the patient¿s soft tissue laxity as notes from the primary surgery confirm there was no tendency towards subluxation at all.A review of the complaint database over the last 3 years has found 1 similar complaint for the item code 159576, 5 similar complaints for the item code 161469 and 1 similar complaint found for the item 154725.There were no trends identified from the complaint history review.No same lot numbers, no same hospitals and there are no trends in the cause.In most cases of similar complaints, the cause could not be established.Without the opportunity to examine the complaint product, the root cause cannot be determined due to insufficient information.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.Product not returned.
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