|
Model Number N/A |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
|
Patient Problem
Bacterial Infection (1735)
|
Event Date 12/03/2020 |
Event Type
Injury
|
Manufacturer Narrative
|
(b)(4).The device will not be returned for analysis, due to location of device is unknown; however, an investigation of the reported event is in progress.Once the investigation has been completed, a follow-up mdr will be submitted.
|
|
Event Description
|
It was reported that the patient underwent initial left total hip arthroplasty.Subsequently, patient had a possible i & d approximately 1 month later.The patient was revised approximately 2 months post implantation due to deep infection.Attempts have been made and additional information on the reported event is unavailable at this time.
|
|
Manufacturer Narrative
|
D10: explanted product stage 1: acetabular cup ¿ 110010247, lot 6815876 acetabular liner ¿ 30123607, lot 64802478 femoral head component ¿ 6500661, lot 3030565 femoral stem ¿ 51103160, lot 6454785 explanted product stage 2: djo bone cement ref 600-15-000 lot 939d1d0042 g7 liner ref 30123607 lot 64926920 depuy head and spacer.
|
|
Event Description
|
It was reported that the patient underwent initial left total hip arthroplasty.Subsequently, the patient underwent stage 1 revision due to infection approximately 1 month later.Stage 2 reimplantation occurred approximately 3 months later.No further event information available at the time of this report.
|
|
Manufacturer Narrative
|
Upon reassessment of the reported event, the device was determined to be not reportable.During the investigation process a review of the sterile certifications were reviewed and found to be conforming with no applicable deviations.Devices were verified to have gone through acceptable sterilization process following iso/aami/astm & eu published guidelines.There are multiple factors that may contribute to an infection that are outside the control of zimmer biomet, such as external factors, i.E.Hospital/surgical environment, provider related risk factors, and/or patient comorbidities/risk factors.As there are no indications of a product or process issues identified affecting implant safety or effectiveness, therefore implanted products are not identified as the source or contributing to the reported infection.The initial report was forwarded in error and should be voided.
|
|
Event Description
|
Upon reassessment of the reported event, the device was determined to be not reportable.During the investigation process a review of the sterile certifications were reviewed and found to be conforming with no applicable deviations.Devices were verified to have gone through acceptable sterilization process following iso/aami/astm & eu published guidelines.There are multiple factors that may contribute to an infection that are outside the control of zimmer biomet, such as external factors, i.E.Hospital/surgical environment, provider related risk factors, and/or patient comorbidities/risk factors.As there are no indications of a product or process issues identified affecting implant safety or effectiveness, therefore implanted products are not identified as the source or contributing to the reported infection.The initial report was forwarded in error and should be voided.
|
|
Search Alerts/Recalls
|
|
|