ZIMMER SWITZERLAND MANUFACTURING GMBH NCB PERIPROSTHETIC FEMUR PLATE, DISTAL, LEFT, 15 HOLES, 317 MM; NCB PERIPROSTHETIC FEMUR POLYAXIAL LOCKING PLATE SYSTEM
|
Back to Search Results |
|
Model Number N/A |
Device Problem
Fracture (1260)
|
Patient Problems
Failure of Implant (1924); Non-union Bone Fracture (2369); Insufficient Information (4580)
|
Event Date 07/02/2021 |
Event Type
Injury
|
Manufacturer Narrative
|
The manufacturer received 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.As no lot number was provided, the device history records could not be reviewed.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).
|
|
Event Description
|
Patient was implanted on an unknown side and a underwent revision surgery due to implant fracture.
|
|
Event Description
|
Investigation results are now available.
|
|
Manufacturer Narrative
|
Investigation results were made available.1.Event description: it was reported that the patient was implanted on (b)(6) 2021 and underwent revision surgery on (b)(6) 2021 due to implant fracture.Harm: s3 - bone malunion/non-union, resulting in revision or other interventions hazardous situation: fragments of an implant and/or bone are generated in vivo.2.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 the plate is fractured and is mildly displaced.There is also an oblique nonunion of the fracture of the distal femur.3.Product evaluation: no product was returned; therefore, visual and dimensional evaluation could not be performed.4.Review of product documentation: document review could not be performed due to unknown product identification.Device purpose: this device is intended for treatment.Product compatibility: the compatibility check could not be performed as only the complained product is known.5.Conclusion: it was reported that the patient was implanted on (b)(6) 2021 and underwent revision surgery on (b)(6) 2021 due to implant fracture.Based on the investigation the reported event can be confirmed.Due to significant lack of information a detailed investigation could not be performed, nevertheless based on the given information there is no indication of a nonconformance or 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 (b)(4).
|
|
Search Alerts/Recalls
|
|
|