Model Number TPS-101-1112 |
Device Problems
Loose or Intermittent Connection (1371); Appropriate Term/Code Not Available (3191)
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Patient Problem
Insufficient Information (4580)
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Event Date 06/19/2022 |
Event Type
Injury
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Manufacturer Narrative
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It was reported that replacement poly inserts have been requested for revision surgery.Reason for revision is laxity.Primary surgery occurred on (b)(6) 2022.Revision surgery is planned for (b)(6) 2022.The device history record was reviewed and the device was manufactured per the specifications.All sterilisation requirements were met.
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Event Description
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It was reported that replacement poly inserts have been requested for revision surgery.Reason for revision is laxity.Primary surgery occurred on (b)(6) 2022.Revision surgery is planned for (b)(6) 2022.
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Search Alerts/Recalls
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