STRYKER ORTHOPAEDICS-MAHWAH RESTORATION (TM) ADM. CUP W/HA; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED
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Catalog Number 1235-2-522 |
Device Problems
Material Distortion (2977); Noise, Audible (3273)
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Patient Problems
Pain (1994); Injury (2348)
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Event Date 01/29/2018 |
Event Type
Injury
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Manufacturer Narrative
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It was noted that the device is not available for evaluation.If additional information is received, it will be provided in a supplemental report upon completion of the investigation.The following devices were also listed in this report: restoration adm x3 ins 28/52; 1236-2-852; (b)(4); delta v-40 ceramic head 28/0; 6570-0-128; (b)(4).It cannot be determined which, if any of these devices may have caused or contributed to the patient's experience.Not returned.
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Event Description
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As reported: "this patient was participating in stryker's restoration adm x3 study.As per the adverse event form, the patient had pain due to aggressive workouts and lower body exercises with weights.As per the operative note, the patient was revised due to a failed hip replacement secondary to impingement".
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Manufacturer Narrative
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Additional information: b5 - executive summary; d4 - gtin.An event regarding pain and range of motion issues involving an adm shell was reported.The medical review confirmed pain but could not determine a root cause and did not confirm the range of motion issues.Method & results: -product evaluation and results: not performed as the device was not returned.-medical records received and evaluation: a review of the provided medical records and x-rays by a clinical consultant indicated: narrative: patient underwent a primary tha with mobile bearing adm acetabular component on (b)(6) 2015.Post operatively the patient experienced intermittent groin pain particularly with vigorous exercise and complained of grinding and squeaking.The pain became progressively worse and attempts to treat this pain with injections in the priformis and psoas bursa were unsuccessful.On (b)(6) 2018 the patient was returned to the or and the adm mobile bearing acetabular component was removed and a new fixed bearing component ( zimmer) was implanted.At time of revision the surgeon noted impingement of the ¿neck to socket¿.No other mechanical issue was identified.Pre revision xrays demonstrate a pressfit tha that appears well fixed and without mechanical complication.Acetabular component orientation is horizontally inclined but still within the ¿safe zone¿ of positioning.Conclusion of assessment: review of these records confirms the patient had groin pain following a primary tha and revision surgery occurred, however, the root cause cannot be determined as insufficient information was available documentation which would aid in the further completion of this assessment would include: dated post op x-rays, injection procedure notes and imaging, outpatient office/clinic notes, implant retrieval.Product history review: a review of the device manufacturing records indicate that all devices accepted into final stock were free from discrepancies.Complaint history review: there were no other events for the lot provided.Conclusions: the medical review concluded: at time of revision the surgeon noted impingement of the ¿neck to socket¿.No other mechanical issue was identified.Pre revision xrays demonstrate a pressfit tha that appears well fixed and without mechanical complication.Acetabular component orientation is horizontally inclined but still within the ¿safe zone¿ of positioning.Review of these records confirms the patient had groin pain following a primary tha and revision surgery occurred, however, the root cause cannot be determined as insufficient information was available.Documentation which would aid in the further completion of this assessment would include: dated post op x-rays.Injection procedure notes and imaging.Outpatient office/clinic notes.Implant retrieval.No further investigation for this event is possible at this time as no devices and insufficient information was received by stryker orthopaedics.If devices and / or additional information become available to indicate further evaluation is warranted, this record will be reopened.
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Event Description
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As reported: "this patient was participating in stryker's restoration adm x3 study.As per the adverse event form, the patient had pain due to aggressive workouts and lower body exercises with weights.As per the operative note, the patient was revised due to a failed hip replacement secondary to impingement." update 18 july, 2018: medical review by a clinician concluded the following: "review of these records confirms the patient had groin pain following a primary tha and revision surgery occurred; however, the root cause cannot be determined as insufficient information was available." medical review also states "at time of revision the surgeon noted impingement of the ¿neck to socket.¿ no other mechanical issue was identified.Pre revision xrays demonstrate a pressfit tha that appears well fixed and without mechanical complication.Acetabular component orientation is horizontally inclined but still within the ¿safe zone¿ of positioning." impingement was not confirmed.
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