| Model Number N/A |
| Device Problems
Activation, Positioning or Separation Problem (2906); Activation Problem (4042)
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| Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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| Event Date 03/08/2021 |
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Event Type
malfunction
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Manufacturer Narrative
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(b)(4).Initial report.Report source, foreign: event occurred in (b)(6).Patient information is not allowed by country regulations.The product has been requested to be returned to zimmer biomet for investigation.Concomitant medical products: exc abt rnglc-x shl ha/pc 056m, catalog #: 131356ha, lot #: 6756638.Multiple mdr reports were filed for this event, please see associated reports: 3002806535-2021-00086.(b)(6).The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.
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Event Description
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It was reported that during a hip replacement the surgeon could not get the acetabular shell and liner to fit correctly.On inspection of both components it appeared that during the insertion of the abt ringlock shell the actual ringlock component of the shell dislodged and subsequently changed shape therefore not accepting the liner and damaging the liner.Both shell and liner were removed and replaced with new implants, which were inserted without further incident.Damaged implants safely removed from sterile field and passed to theatre clinical lead for further inspection.No harm to patient.
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Event Description
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It was reported that during a hip replacement the surgeon could not get the acetabular shell and liner to fit correctly.On inspection of both components it appeared that during the insertion of the abt ringlock shell the actual ringlock component of the shell dislodged and subsequently changed shape therefore not accepting the liner and damaging the liner.Both shell and liner were removed and replaced with new implants, which were inserted without further incident.Damaged implants safely removed from sterile field and passed to theatre clinical lead for further inspection.No harm to patient.
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Manufacturer Narrative
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(b)(4).Complaint summary: products have been returned to biomet uk ltd for evaluation and forwarded to the complaints product evaluation engineer for investigation.The complaint states: upon impaction of the ringloc x shell, the ring came out and was repositioned and the liner impacted.It appeared that the ring was bent and also locked away from the viewing window so unable to check if locking mechanism had worked accordingly.Shell and liner removed and replaced with new implants.During a hip replacement the surgeon could not get the acetabular shell and liner to fit correctly.On inspection of both components it appeared that during the insertion of the abt ringlock shell the actual ringlock component of the shell dislodged and subsequently changed shape therefore not accepting the liner and damaging the liner.Both shell and liner were removed and replaced with new implants - which were inserted without further incident.Damaged implants safely removed from sterile field and passed to theatre clinical lead for further inspection.No harm to patient.The reported event occurred during surgery.No health consequences or impact.Review of returned product confirms that the locking ring is dislodged from the shell and visible dame to outside diameter of liner.Visual inspection of shell confirms that the ring is protruding from the ringloc slot.On review of the liner it was confirmed that the outside diameter was damaged on one side which suggest that the liner was not positioned correctly on insertion by the user.Dimensional check not required as the returned product was damaged.No assembly checks carried out as the ring and liner were both damaged.Review of raw material certificate of conformance confirms that material conforms to specification.The likely cause of the reported event is incorrect insertion of liner causing damage and dislodging to both locking ring and liner bearing surface.The surgical technique describes the correct insertion method and states that: the definitive acetabular liner should only be inserted into the acetabular shell once the shell is deemed to be stable and placed in the correct inclination and orientation.Failure to follow this instruction may cause premature implant failure.The definitive e1 ringloc-x liner should be positioned initially by hand into the shell ensuring that it is correctly aligned both radially and longitudinally.Investigation is completed based on current available information.If any additional information becomes available, then the complaint will be reopened and investigated.A review of mhr/associated inspection records and raw material certs suggests that product left zb conforming to specification.Mhr records three non-conformity reports, however these were approved concessions and have no impact to the reported event: instrument compatibility review not required.Issue does not relate to a combination of implants/instruments.A review of the complaint database over the last 3 years did not show any capa or hhed associated to this complaint category.No corrective action required at this time.Both the severity and occurrence of the reported event are in line with the risk file.No harm to patient has been reported.Both items were distributed conforming.The hazard and reported harm are covered by the risk file and the severity/occurrence and the risk scores are within acceptable limits.The overall risk is considered to be low.Capa: no corrective or preventive action required at this time.Multiple mdr reports were filed for this event, please see associated reports: 3002806535-2021-00086-1 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.
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