Model Number N/A |
Device Problems
Insufficient Information (3190); Appropriate Term/Code Not Available (3191)
|
Patient Problem
No Information (3190)
|
Event Type
Injury
|
Manufacturer Narrative
|
Concomitant medical products: unknown liner; catalog#: unknown; lot#: unknown.Unknown head; catalog#: unknown; lot#: unknown.Unknown stem; catalog#: unknown; lot#: unknown.Therapy date: unknown.The manufacturer did not receive x-rays, or other source documents for review.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.(b)(4).
|
|
Event Description
|
Patient was implanted on an unknown side and is indicated for the revision surgery due to unknown reasons.It is unknown if the revision surgery has been performed.
|
|
Event Description
|
No change to previously reported event.
|
|
Manufacturer Narrative
|
This follow-up report is being submitted to relay corrected and additional information.Event description: it was reported that patient underwent an initial total hip arthroplasty approx.15 years ago.Subsequently, the patient underwent a revision surgery due to polyethylene wear on (b)(6) 2020.The cup was revised as well to place a g7 cup with the dual mobility system.Review of received data: no medical data relevant to the case has been received.Due diligence: no further due diligence required as all required information to support the conclusion is available or was already requested.Product evaluation: no product was returned; therefore, visual and dimensional evaluation could not be performed.Review of product documentation: device purpose: all involved devices are intended for treatment.Product compatibility: the compatibility check could not be performed due to missing product identification.Dhr review: review of the device history records could not be identified due to missing reference and lot number.Conclusion: it was reported that patient underwent an initial total hip arthroplasty approx.15 years ago.Subsequently, the patient underwent a revision surgery due to polyethylene wear on (b)(6) 2020.The cup was revised as well to place a g7 cup with the dual mobility system.Neither x-rays, operative notes nor office visit notes were received.No product was returned or pictures provided; visual and dimensional evaluations could not be performed.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 received description no issue related to the cup was identified, as the cup was only revised to place a dual mobility system, after the inlay had to be replaced due to polyethylene wear after 15 years in-vivo.The need for corrective measures is not indicated and zimmer gmbh considers this case as closed.Zimmer biomet¿s reference number of this file is (b)(4).
|
|
Manufacturer Narrative
|
Additional information which was received on nov 05, 2020.This follow-up report is being filled to relay additional information, which was unknown at the time of the previous medwatch.The manufacturer received other source documents for review.Should additional information become available and / or the device(s) be returned for evaluation and an investigation result be available, that changes this assessment, an amended medical device report will be submitted.Zimmer¿s reference number of this file is cmp- (b)(4).
|
|
Event Description
|
Patient was implanted on an unknown side.And underwent revision surgery date, due to poly wear.
|
|
Search Alerts/Recalls
|