Model Number 1219-32-152 |
Device Problems
Fracture (1260); Device Dislodged or Dislocated (2923)
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Patient Problems
Foreign Body Reaction (1868); Joint Dislocation (2374); Joint Laxity (4526); Unspecified Musculoskeletal problem (4535); Swelling/ Edema (4577); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)
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Event Date 04/29/2021 |
Event Type
Injury
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Manufacturer Narrative
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Product complaint # (b)(4).If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.
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Event Description
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Surgeon reported to bfarm: "dislocation polyethylene inlay with subluxation.".
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Event Description
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Additional information received indicated that there was no surgical delay.Affected side was the left side.
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Manufacturer Narrative
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Product complaint # (b)(4).This report is being submitted pursuant to the provisions of 21 cfr, part 803.This report may be based on information which has not been investigated or verified prior to the required reporting date.This report does not reflect a conclusion by depuy synthes joint reconstruction, or its employees that the report constitutes an admission that the product, depuy synthes joint reconstruction, or its employees caused or contributed to the potential event described in this report.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.H6 clinical code: appropriate term / code not available (e2402) is used to capture injury (e20).
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Manufacturer Narrative
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Product complaint # (b)(4).Investigation summary: examination of the returned device and provided images found evidence to support disassociation of the liner from the cup while implanted.A fracture of the device was also found.This device was manufactured on 29-dec-2019.Depuy considers the investigation closed.Should additional info be received, the investigation will be re-opened as necessary.Device history lot: 1) quantity manufactured: (b)(4).2) date of manufacture: 29-dec-2019.3) any anomalies or deviations identified in dhr: none.4) expiry date: 30-nov-2024.5) ifu reference: (b)(4).
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Event Description
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On (b)(6) 2021, the patient was noted to have had a dislocation of the polyethylene inlay with subluxation.Prior to surgery, the indications for surgery included squeaking.The surgeon reported finding clear effusion, metallosis, inlay with shoulder twisted and shifted and shifted in caudal direction.The insert was noted to be deformed with significant damage on the edges.The insert had shifted in a caudal direction.The cup based had marked anteversion, but was not revised.The insert and femoral head were revised.
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Manufacturer Narrative
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Product complaint # (b)(4).This report is being submitted pursuant to the provisions of 21 cfr, part 803.This report may be based on information which has not been investigated or verified prior to the required reporting date.This report does not reflect a conclusion by depuy synthes joint reconstruction, or its employees that the report constitutes an admission that the product, depuy synthes joint reconstruction, or its employees caused or contributed to the potential event described in this report.H10 additional narrative: if information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.
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Manufacturer Narrative
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Product complaint # (b)(4).This report is being submitted pursuant to the provisions of 21 cfr, part 803.This report may be based on information prior to the required reporting date.This report does not reflect a conclusion by depuy synthes joint reconstruction, or its employees that the report constitutes an admission that the product, depuy synthes joint reconstruction, or its employees caused or contributed to the potential event described in this report.Updated: h6 (clinical code) to capture unspecified musculoskeletal problem (e1635) - joint injury.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.
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Search Alerts/Recalls
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