(b)(4).Customer has indicated that the product will not be returned to zimmer biomet for investigation, due to unknown product location.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.Concomitant medical products: 51-107120, tprlc 133 mp type1 pps ho 12.0, 3863366, 12-115120, cer bioloxd mod hd 36mm -3 nk, 055620, 110017105, g7 finned 4 hole shell 56f, 3757306, 010000999, g7 screw 6.5mm x 30mm, 3937201.Multiple mdr reports were filed for this event, please see associated reports: 0001825034 - 2018 - 07151, 0001825034 - 2018 - 07152, 0001825034 - 2018 - 07154, 0001825034 - 2018 - 07156.
|
This follow-up report is being submitted to relay additional information.Reported event was confirmed by review of operative notes.During the stage 1 revision patient was revised for pain and infection.During the surgery, purulent fluid was noted.The stem was noted to be well fixed while the acetabular cup was found to be loose.Nonviable tissue was debrided and cement spacer was implanted.During the stage 2 revision, patient was noted to have normalized inflammatory markers and well-healed wound.Cement spacer was removed and devices were reimplanted.Device history record (dhr) review was unable to be performed as the lot number of the device involved in the event is unknown.Root cause was unable to be determined as the necessary information to adequately investigate the reported event was not provided.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.
|
It was reported patient underwent total hip arthroplasty and presented at 7.5 months post operatively with worsening pain in the right hip.Workup revealed periprosthetic joint infection, and loosening of the acetabular component.Patient underwent 2 stage exchange including radical debridement and delayed reimplantation.During the stage 2 revision, patient experienced about 800 ml of blood loss.Patient was also noted to have significant heterotropic bone and a large trochanter fragment requiring placement of a supercable.Devices were implanted with no noted complications.
|