Model Number N/A |
Device Problem
Appropriate Term/Code Not Available (3191)
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Patient Problem
Pain (1994)
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Event Date 08/30/2017 |
Event Type
Injury
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Manufacturer Narrative
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(b)(4).Concomitant medical products: medical product: epoly rlc 10 deg 28mm sz22, catalog #: ep-105812, lot #: 368460; medical product: rnglc locking ring sz 22, catalog #: 105422, lot #: 021130; medical product: unk cup, catalog #: not reported, lot #: not reported; medical product: unk stem, catalog #: not reported, lot #: not reported.The investigation is in process.Once the investigation is complete, a follow-up mdr will be submitted.
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Event Description
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It was reported by legal counsel that a patient underwent a left hip arthroplasty.Subsequently, the patient was revised due to pan.During the procedure, inspection of the joint space showed that there were multiple fragments of polyethylene, that the prosthetic femoral head was articulating with the acetabular shell, and that there was striping over the weight bearing portion.All products were revised.This report is based on allegations set forth in patients notice and the allegations there in are unverified.
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Event Description
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It was reported by legal counsel that a patient underwent a left hip arthroplasty.Subsequently, the patient was revised due to pain and wear.During the procedure, inspection of the joint space showed that there were multiple fragments of polyethylene, that the prosthetic femoral head was articulating with the acetabular shell, and that there was striping over the weight bearing portion.All products were revised.This report is based on allegations set forth in patients notice and the allegations there in are unverified.
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Manufacturer Narrative
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(b)(4).This report is to relay additional information.A review of the manufacturing history records confirms no abnormalities or deviations reported.Without the opportunity to examine the complaint product, the root cause cannot be determined due to insufficient information.If any additional information becomes available, then the complaint will be reopened and investigated thoroughly.
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Manufacturer Narrative
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(b)(4).This follow-up report is being submitted to relay additional information.Unique identifier (udi) number: (b)(4).The investigation is in process.Once the investigation is complete, a follow-up mdr will be submitted.
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Event Description
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It was reported by legal counsel that a patient underwent a left hip arthroplasty.Subsequently, the patient was revised due to pain and wear.During the procedure, inspection of the joint space showed that there were multiple fragments of polyethylene, that the prosthetic femoral head was articulating with the acetabular shell, and that there was striping over the weight bearing portion.All products were revised.This report is based on allegations set forth in patients notice and the allegations there in are unverified.
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Manufacturer Narrative
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(b)(4).This final follow-up report is being submitted to relay additional information.We have been provided with the patients date of birth (on (b)(6) 1946).If any further information is found which would change or alter any conclusions or information, a supplemental will be submitted accordingly.Zimmer biomet will continue to monitor for trends.H3 other text: item not returned to manufacturer.
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Event Description
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Left hip revision due to pain and wear.It was reported by legal counsel that a patient underwent a left hip arthroplasty.Subsequently, the patient was revised due to pain and wear.During the procedure, inspection of the joint space showed that there were multiple fragments of polyethylene, that the prosthetic femoral head was articulating with the acetabular shell, and that there was striping over the weight bearing portion.All products were revised.This report is based on allegations set forth in patients notice and the allegations there in are unverified.
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Search Alerts/Recalls
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