ZIMMER BIOMET, INC. VERSA-DIAL 46X27X46 HUM HEAD; PROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER, UNCEMENTED/EXTREMITIES
|
Back to Search Results |
|
Model Number 113048 |
Device Problems
Unstable (1667); Adverse Event Without Identified Device or Use Problem (2993)
|
Patient Problems
Erosion (1750); Failure of Implant (1924)
|
Event Type
Injury
|
Manufacturer Narrative
|
(b)(4).The product was initial reported on mfr:0001822565-2022-02451.Multiple mdr reports were filed for this event, please see associated reports: 0001825034-2022-02403, 0001825034-2022-02405, 0001825034-2022-02406.Concomitant medical products: item#: 113952, sm hybrid glenoid base 4mm; lot#: 539300, item#: pt-113950, pt hybrid glen post regenerex; lot#: 960770, item#: 118001, versa-dial/comp ti std taper; lot#: 057540, item#: 113653, comp primary stem 13mm std; lot#: 987670.Customer has indicated that the product will not be returned to zimmer biomet for investigation, as the product remains implanted.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.
|
|
Event Description
|
It was reported that the patient underwent a right shoulder arthroplasty on an unknown date.Subsequently, the patient is being considered for a revision surgery due to bone erosion and instability on an unknown date.However, no revision procedure has been reported to date.
|
|
Manufacturer Narrative
|
Cmp-(b)(4).This follow-up report is being submitted to relay additional information.Multiple mdr reports were filed for this event, please see associated reports: 0001825034-2022-02403-1 0001825034-2022-02405-1 h6: component codes: mechanical (g04) - head no product was returned, or pictures provided; visual and dimensional evaluations could not be performed.Review of the device history record(s) identified no deviations or anomalies during manufacturing related to the reported event.Medical records were not provided.It remains that a definitive root cause cannot 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.
|
|
Event Description
|
No further event information available at the time of this report.
|
|
Search Alerts/Recalls
|
|
|