Model Number N/A |
Device Problem
Inadequacy of Device Shape and/or Size (1583)
|
Patient Problem
Discomfort (2330)
|
Event Date 07/17/2023 |
Event Type
Injury
|
Manufacturer Narrative
|
(b)(4).D10 ¿ unknown ms-30 stem, item#unknown, lot#unknown, unknown, liner item#unknown, lot#unknown.G2 ¿ foreign ¿ new zeland.Multiple mdr reports were filed for this event, please see associated reports: 0009613350-2023-00442, 0009613350-2023-00443.The device will not be returned for analysis; however, an investigation of the reported event is in progress.Once the investigation is completed, a supplemental medwatch 3500a will be submitted.H3 other text : device discarded.
|
|
Event Description
|
It was reported that the patient complained of a feeling of discomfort potentially caused by the sizing of implant.Due diligence is in progress for this complaint; to date no additional information or product has been received.
|
|
Event Description
|
No further event information available at the time of this report.
|
|
Manufacturer Narrative
|
(b)(4).This follow-up report is being submitted to relay additional information.The following sections were updated: b4, b5, d9, g3, g6, h1, h2, h3, h6, h10.No product was returned or pictures provided; visual and dimensional evaluations could not be performed.Review of manufacturing records cannot be performed without product identification.Devices are used for treatment.Medical records were not provided.With the available information, a definitive root cause cannot be determined.If any further information is found which would change or alter any conclusions or information, a supplemental report will be filed accordingly.Zimmer biomet will continue to monitor for trends.H3 other text : product is discarded.
|
|
Search Alerts/Recalls
|
|