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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH RESTORATION (TM) ADM. CUP W/HA; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED
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STRYKER ORTHOPAEDICS-MAHWAH RESTORATION (TM) ADM. CUP W/HA; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED Back to Search Results
Catalog Number 1235-2-522
Device Problems Material Distortion (2977); Noise, Audible (3273)
Patient Problems Pain (1994); Injury (2348)
Event Date 01/29/2018
Event Type  Injury  
Manufacturer Narrative
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.
 
Event Description
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".
 
Manufacturer Narrative
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.
 
Event Description
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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Brand Name
RESTORATION (TM) ADM. CUP W/HA
Type of Device
PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED
Manufacturer (Section D)
STRYKER ORTHOPAEDICS-MAHWAH
325 corporate drive
mahwah NJ 07430
MDR Report Key7533043
MDR Text Key108873948
Report Number0002249697-2018-01514
Device Sequence Number1
Product Code LPH
Combination Product (y/n)N
PMA/PMN Number
K121308
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type health professional,other
Type of Report Initial,Followup
Report Date 08/17/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received05/22/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Health Professional
Device Expiration Date06/30/2018
Device Catalogue Number1235-2-522
Device Lot NumberG3659923
Was Device Available for Evaluation? No
Date Manufacturer Received07/20/2018
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Hospitalization; Required Intervention;
Patient Age63 YR
Patient Weight89
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