Catalog Number 9111122 |
Device Problems
Device Dislodged or Dislocated (2923); Naturally Worn (2988); Noise, Audible (3273)
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Patient Problems
Edema (1820); Necrosis (1971); Seroma (2069); Joint Dislocation (2374); No Code Available (3191)
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Event Date 03/11/2019 |
Event Type
Injury
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Manufacturer Narrative
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(b)(4).The devices were reviewed by bioengineering and a report was received stating it is unlikely that a potential product issue was present.Root cause undetermined.Depuy synthes considers the investigation closed at this time.Should additional information be received, the information will be reviewed and the investigation may be re-opened as necessary.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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Revision of hip-tep (inlay and head) left side as pe inlay disassociated from the cup.The head caused metal wear at the inner side of the pinnacle cup.Doi: unknown, dor: (b)(6) 2019.
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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.¿ no code available is used to capture extraskeletal ossification, bone disorder, joint injury, device revision or replacement.
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Event Description
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After review of clinical report, patient was revised to address mechanical complication, hip tep, and pe inlay luxated and abrasion of cup against the ceramic head, left hip tep.The ct examination of boney pelvis on (b)(6) 2019 showed a status post hip tep implantation, left with firm fit of the shaft and the prosthetic cup.Eccentric posterior apical position of the prosthesis head in the cup due to dislocation or rotation of the inlay toward ventral from the cup, an inlay fracture cannot be ruled out.In axial slicing, fluid retention measuring 6.5 x 4 x 7 cm lateral of the left greater trochanter, dd: seroma in the surgical access route.Moderate cox arthrosis, right.Isg arthrosis bilaterally.Erosive osteochondrosis l5/s1 and facet joint arthrosis l3 to s1.Doi: (b)(6) 2019 - dor: (b)(6) 2019 (left hip).
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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.
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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: corrected: a2 (birth date).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).Investigation summary : the devices were reviewed by bioengineering and a report was received stating it is unlikely that a potential product issue was present.Root cause undetermined.Depuy synthes considers the investigation closed at this time.Should additional information be received, the information will be reviewed and the investigation may be re-opened as necessary.Updated 02 november 2020 re-open.The complaint was re-opened upon receiving further correspondence.The information received did not change the original investigation report.
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Search Alerts/Recalls
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