Catalog Number 136555000 |
Device Problems
Material Integrity Problem (2978); Naturally Worn (2988); Insufficient Information (3190)
|
Patient Problems
Host-Tissue Reaction (1297); Edema (1820); Pain (1994); Loss of Range of Motion (2032); Blurred Vision (2137); Distress (2329); Injury (2348); Deformity/ Disfigurement (2360); Joint Disorder (2373); Ambulation Difficulties (2544); Limited Mobility Of The Implanted Joint (2671); Not Applicable (3189); No Code Available (3191)
|
Event Date 02/28/2018 |
Event Type
Injury
|
Manufacturer Narrative
|
If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.
|
|
Event Description
|
Pinnacle litigation record received.Litigation alleges pain, loss of mobility, loss of range of motion, mental anguish, disfigurement, corrosion and friction wear which caused amounts of toxic cobalt-chromium metal debris and physical,mental and emotional injuries.Doi: (b)(6) 2008; dor: (b)(6) 2018 ; left hip.
|
|
Manufacturer Narrative
|
Product complaint # (b)(4).Investigation summary: no device associated with this report was received for examination.A worldwide lot specific complaint database search, or device history record (dhr) review, was not possible because the required lot code(s) was not provided.Device history lot: null.Device history batch: null.Device history review: null.If information is obtained that was not available for the initial medwatch, a follow-up medwatch, a follow-up medwatch will be filed as appropriate.
|
|
Manufacturer Narrative
|
Depuy synthes is submitting this report pursuant to the provision of 21 cfr, part 803.The report may be based on the information which depuy synthes has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy synthes or its employees that the report constitutes an admission that the device, depuy synthes, or its employees caused or contributed to the potential event described in this report.Product complaint#: (b)(4).Investigation summary: no device associated with this report was received for examination.A worldwide lot specific complaint database search, or device history record (dhr) review, was not possible because the required lot code(s) was not provided.Device history lot: null.Device history batch: null.Device history review: null.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.
|
|
Event Description
|
Pfs alleges blurred vision.
|
|
Manufacturer Narrative
|
Depuy synthes is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on information which depuy synthes has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy synthes or its employees that the report constitutes an admission that the device, depuy synthes, or its employees caused or contributed to the potential event described in this report.Udi: (b)(4).
|
|
Manufacturer Narrative
|
Depuy synthes is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on information which depuy synthes has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy synthes or its employees that the report constitutes an admission that the device, depuy synthes, or its employees caused or contributed to the potential event described in this report.Additional narrative: udi: (b)(4).
|
|
Event Description
|
In addition to what was previously reported, ppf alleged pseudotumor.After review of medical records, the patient was revised to address bearing wear and associated fluid accumulation.Operative note reported of some gross joint fluid.
|
|
Manufacturer Narrative
|
Depuy synthes is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on information which depuy synthes has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy synthes or its employees that the report constitutes an admission that the device, depuy synthes, or its employees caused or contributed to the potential event described in this report.Product complaint #: (b)(4).Investigation summary: no device associated with this report was received for examination.A worldwide lot specific complaint database search, or device history record (dhr) review, was not possible because the required lot code(s) was not provided.If information is obtained that was not available for the initial medwatch, a follow-up medwatch, a follow-up medwatch will be filed as appropriate.
|
|
Manufacturer Narrative
|
Depuy synthes is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on information which depuy synthes has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy synthes or its employees that the report constitutes an admission that the device, depuy synthes, or its employees caused or contributed to the potential event described in this report.Udi: (b)(4).Patient code: no code available ((b)(4)) used to capture the medical device removal and limb asymmetry.
|
|
Event Description
|
Pfs alleges hair loss, blurred vision, pain, limb asymmetry, and walking difficulty.After review of medical records, patient was revised to address failed left total hip arthroplasty with bearing wear and associated fluid accumulation.Operative notes stated of some gross joint fluid when the underlying implants were exposed.The hip was stable throughout a full range of motion anteriorly with minimal instability.
|
|
Search Alerts/Recalls
|