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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH PRIM BP W/HOLES BEAD W/PA SZ 3; PROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, SEMI-CONSTRAINED, UNCEMENTED, POROUS, CO
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STRYKER ORTHOPAEDICS-MAHWAH PRIM BP W/HOLES BEAD W/PA SZ 3; PROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, SEMI-CONSTRAINED, UNCEMENTED, POROUS, CO Back to Search Results
Catalog Number 5527B300
Device Problem Noise, Audible (3273)
Patient Problems Pain (1994); Swelling (2091); Weakness (2145)
Event Date 12/01/2016
Event Type  Injury  
Manufacturer Narrative
Review of the device history records indicates devices were manufactured and accepted into final stock with no reported discrepancies.There have been no other events for the lot referenced.An evaluation of the device cannot be performed as the device was not returned to the manufacturer.Should additional information become available it will be reported in a supplemental report upon completion of the investigation.
 
Event Description
As reported through mw5078695 "patient reports she was unable to get up from her bed one morning due to severe pain in her knee.She reports hearing clicks while walking and has experienced weakness, swelling and buckling.Her orthopedic surgeon saw "something sticking out of her bone" and mentioned that "something pulls away" when she moves her knee.Patient is worried her implant may have been recalled.The patient is wearing a knee brace for support and can no longer hear the clicking noise; however, her other symptoms persist.".
 
Manufacturer Narrative
An event regarding instability involving a triathlon baseplate was reported.The event was not confirmed.Method & results: device evaluation and results: not performed as no product was returned for evaluation.Medical records received and evaluation: a review of the provided medical records by a clinical consultant indicated: on (b)(6) 2018 a note states, ¿seen (b)(6) 2018 and diagnosed with unstable right tkr.Reports ascending and descending stairs virtually impossible.Reports clicking sound and sensation with weightbearing.Physical examination: 0° to 120° with jog of laxity in full extension and 90°.Ap drawer test negative.Plan: bledsoe brace, strengthening exercises, return in two months.¿ no documented follow-up subsequent to this visit is available.X-ray printouts include multiple views of the right knee, all undated, demonstrating a right posterior stabilized total knee arthroplasty, uncemented, with four screws in the tibial baseplate.The knee is reduced and the components are in nominal position.There is no evidence of loosening or pathology noted.On (b)(6) 2018 a note states, ¿seen (b)(6) 2018 and diagnosed with unstable right tkr.Reports ascending and descending stairs virtually impossible.Reports clicking sound and sensation with weightbearing.Physical examination: 0° to 120° with jog of laxity in full extension and 90°.Ap drawer test negative.Plan: bledsoe brace, strengthening exercises, return in two months.¿ no documented follow-up subsequent to this visit is available.X-ray printouts include multiple views of the right knee, all undated, demonstrating a right posterior stabilized total knee arthroplasty, uncemented, with four screws in the tibial baseplate.The knee is reduced and the components are in nominal position.There is no evidence of loosening or pathology noted.The event description states, ¿she reports having clicks while walking and has weakness, swelling, and buckling wearing a knee brace for support and can no longer hear the clicking." device history review: indicated all devices were manufactured and accepted into final stock with no reported discrepancies.Complaint history review: there have been no other similar events for the lot referenced.Conclusion: a review of the provided medical records by a clinical consultant indicated: a review of the provided medical records by a clinical consultant indicated: on (b)(6) 2018 a note states, ¿seen (b)(6) 2018 and diagnosed with unstable right tkr.Reports ascending and descending stairs virtually impossible.Reports clicking sound and sensation with weightbearing.Physical examination: 0° to 120° with jog of laxity in full extension and 90°.Ap drawer test negative.Plan: bledsoe brace, strengthening exercises, return in two months.¿ no documented follow-up subsequent to this visit is available.X-ray printouts include multiple views of the right knee, all undated, demonstrating a right posterior stabilized total knee arthroplasty, uncemented, with four screws in the tibial baseplate.The knee is reduced and the components are in nominal position.There is no evidence of loosening or pathology noted.On (b)(6) 2018 a note states, ¿seen (b)(6) 2018 and diagnosed with unstable right tkr.Reports ascending and descending stairs virtually impossible.Reports clicking sound and sensation with weightbearing.Physical examination: 0° to 120° with jog of laxity in full extension and 90°.Ap drawer test negative.Plan: bledsoe brace, strengthening exercises, return in two months.¿ no documented follow-up subsequent to this visit is available.X-ray printouts include multiple views of the right knee, all undated, demonstrating a right posterior stabilized total knee arthroplasty, uncemented, with four screws in the tibial baseplate.The knee is reduced and the components are in nominal position.There is no evidence of loosening or pathology noted.The event description states, ¿she reports having clicks while walking and has weakness, swelling, and buckling wearing a knee brace for support and can no longer hear the clicking.It is also noted that the patient inquired if the product was part of the recall.A letter from stryker orthopedics dated october 29, 2018 states, ¿none of these products have been involved in a recall.No further investigation is required at this time.If additional information becomes available to indicate further evaluation is warranted, this record will be reopened.
 
Event Description
As reported through mw5078695 "patient reports she was unable to get up from her bed one morning due to severe pain in her knee.She reports hearing clicks while walking and has experienced weakness, swelling and buckling.Her orthopedic surgeon saw "something sticking out of her bone" and mentioned that "something pulls away" when she moves her knee.Patient is worried her implant may have been recalled.The patient is wearing a knee brace for support and can no longer hear the clicking noise; however, her other symptoms persist.".
 
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Brand Name
PRIM BP W/HOLES BEAD W/PA SZ 3
Type of Device
PROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, SEMI-CONSTRAINED, UNCEMENTED, POROUS, CO
Manufacturer (Section D)
STRYKER ORTHOPAEDICS-MAHWAH
325 corporate drive
mahwah NJ 07430
MDR Report Key7838556
MDR Text Key118943616
Report Number0002249697-2018-02760
Device Sequence Number1
Product Code MBH
UDI-Device Identifier07613327041408
UDI-Public07613327041408
Combination Product (y/n)N
PMA/PMN Number
K141056
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type consumer,other
Type of Report Initial,Followup
Report Date 01/15/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received08/31/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Health Professional
Device Expiration Date02/28/2016
Device Catalogue Number5527B300
Device Lot NumberS3FAB
Was Device Available for Evaluation? No
Date Manufacturer Received12/18/2018
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Hospitalization; Other;
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