Catalog Number UNK HIP FEMORAL AUGMENT |
Device Problems
Adverse Event Without Identified Device or Use Problem (2993); Appropriate Term/Code Not Available (3191)
|
Patient Problems
Hypersensitivity/Allergic reaction (1907); Muscular Rigidity (1968); Pain (1994); Swelling (2091); Distress (2329); Toxicity (2333); Ambulation Difficulties (2544)
|
Event Date 01/01/2017 |
Event Type
Injury
|
Manufacturer Narrative
|
Product complaint # (b)(4).Investigation summary = > the asr platform was voluntarily recalled from the market in august 2010, and the asr product codes are now considered inactive.Further investigation of this individual incident will not be undertaken.The investigation regarding the root cause(s) and/or corrective actions was conducted under mdd capa-(b)(4).Ongoing post market surveillance is conducted per our procedures for this product.Device history lot: 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
|
Asr claim letter alleges physical and psychological agony.It also alleges that patient underwent ten operations including explant and re-implantation of right hip prosthesis.Update (b)(6) 2017: elevated metal ions is alleged.
|
|
Manufacturer Narrative
|
(b)(4).If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.
|
|
Event Description
|
Asr litigation records received alleging increased rigidity, pain, distress, increased blood cobalt levels, loss of ability to walk, injury, disability, pseudotumor, implant wear, joint swelling and walking difficulty.
|
|
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 : the asr platform was voluntarily recalled from the market in august 2010, and the asr product codes are now considered inactive.Further investigation of this individual incident will not be undertaken.The investigation regarding the root cause(s) and/or corrective actions was conducted under mdd capa-001226.Ongoing post market surveillance is conducted per our procedures for this product.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.
|
|
Search Alerts/Recalls
|