MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH TRIATHLON PRIM BEAD PA SZE6 BP; PROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, SEMI-CONSTRAINED, UNCEMENTED, POROUS, CO

Catalog Number 5526B600

Device Problems Mechanical Problem (1384); Malposition of Device (2616); Positioning Problem (3009)

Patient Problems Pain (1994); Injury (2348)

Event Date 05/01/2012

Event Type  Injury  

Manufacturer Narrative

An evaluation of the device cannot be performed as the device was not returned to the manufacturer.Additional information has been requested.Should additional information become available it will be reported in a supplemental report upon completion of the investigation.

Event Description

Sus voluntary event report mw5044894 stated: i waited 18 months to have my left knee replaced with the otismed procedure and after installation it failed.It was installed by dr (b)(6), at (b)(6) orthopedics in (b)(6) 2011.By (b)(6) 2011 it was loose and needed to have a thicker disc installed.A month after this revision it was getting loose again and had 7-8 pain all the time.He could not figure why i had so much pain but said at that time there was nothing more that could be done with it or the pain so i would have to live with it.After he said that i asked dr (b)(6) at (b)(6) to look at my knee and he agreed to attempt to fix my knee.After a ct scan he determined my lower implant was rotated 12 degrees and needed to be replaced again.In (b)(6) of 2013 he did a revision that replaced most of the parts but left the upper implant intact.The lower implant was rotated 12 degrees and also was too large, so a small implant was installed at that time.I still take pain meds to keep the pain below a 4-5 on the pain scale, which i can live with at this time.I thank god that dr (b)(6) was willing to take my case because i could not continue with 7-8 pain.I am using a cane to help me get around but have trouble walking more than a block or so.This report covers: a month after this revision it was getting loose again and had 7-8 pain all the time.He could not figure why i had so much pain but said at that time there was nothing more that could be done with it or the pain so i would have to live with it.After he said that i asked dr (b)(6) at (b)(6) to look at my knee and he agreed to attempt to fix my knee.After a ct scan he determined my lower implant was rotated 12 degrees and needed to be replaced again.In (b)(6) of 2013 he did a revision that replaced most of the parts but left the upper implant intact.Additional information from customer: (this pi to cover) baseplate and insert revised due to loosening.

Manufacturer Narrative

An event regarding alleged malposition involving a triathlon primary fixed bearing baseplate was reported.The event was confirmed.Method & results: device evaluation and results: could not be performed as no items associated with the event were returned or made available for identification or evaluation.Medical records received and evaluation: after review of patient medical records on (b)(6) 2016 and (b)(6) 2016, a clinical consultant concluded inadequate soft tissue balancing and malrotation (malposition) of the tibial component resulted in the symptoms described requiring the second revision surgery on (b)(6) 2013.Device history review: confirmed all devices accepted into finished goods conformed to specification.Complaint history review: a complaint history review confirmed no other similar events for the reported lot.Conclusions: the event was confirmed.Review of provided patient medical records indicated a history of left knee osteoarthritis, pain and instability.Pain and osteoarthritis (degenerative joint disease) led to primary left tka on (b)(6) 2011, instability and pain led to the first revision left tka ((b)(6) 2012), while instability due to malrotation (malposition) of the baseplate led to the second revision left tka ((b)(6) 2013).Additionally, after review of patient medical records on (b)(6) 2016 and (b)(6) 2016, a clinical consultant concluded inadequate soft tissue balancing and malrotation (malposition) of the tibial component resulted in the symptoms described requiring the second revision surgery on (b)(6) 2013.No further investigation for this event is possible at this time.If additional information becomes available, this investigation will be reopened.

Event Description

(b)(6) voluntary event report mw (b)(4) stated: i waited 18 months to have my left knee replaced with the otismed procedure and after installation it failed.It was installed by dr (b)(6), at (b)(6) orthopedics in (b)(6) 2011.By (b)(6) 2011 it was loose and needed to have a thicker disc installed.A month after this revision it was getting loose again and had 7-8 pain all the time.He could not figure why i had so much pain but said at that time there was nothing more that could be done with it or the pain so i would have to live with it.After he said that i asked dr (b)(6) at (b)(6) to look at my knee and he agreed to attempt to fix my knee.After a ct scan he determined my lower implant was rotated 12 degrees and needed to be replaced again.In (b)(6) of 2013 he did a revision that replaced most of the parts but left the upper implant intact.The lower implant was rotated 12 degrees and also was too large, so a small implant was installed at that time.I still take pain meds to keep the pain below a 4-5 on the pain scale, which i can live with at this time.I thank god that dr (b)(6) was willing to take my case because i could not continue with 7-8 pain.I am using a cane to help me get around but have trouble walking more than a block or so.This report covers: a month after this revision it was getting loose again and had 7-8 pain all the time.He could not figure why i had so much pain but said at that time there was nothing more that could be done with it or the pain so i would have to live with it.After he said that i asked dr (b)(6) at (b)(6) to look at my knee and he agreed to attempt to fix my knee.After a ct scan he determined my lower implant was rotated 12 degrees and needed to be replaced again.In (b)(6) of 2013 he did a revision that replaced most of the parts but left the upper implant intact.Additional information from customer: (this pi to cover) baseplate & insert revised due to baseplate rotated 12 degrees.

• Brand Name: TRIATHLON PRIM BEAD PA SZE6 BP
• Type of Device: PROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, SEMI-CONSTRAINED, UNCEMENTED, POROUS, CO
• Manufacturer (Section D): STRYKER ORTHOPAEDICS-MAHWAH; 325 corporate drive; mahwah NJ 07430
• Manufacturer (Section G): STRYKER ORTHOPAEDICS-LIMERICK; raheen business park; limerick NJ NA
• Manufacturer Contact: keyla colon ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 5226974
• MDR Text Key: 31332323
• Report Number: 0002249697-2015-03766
• Device Sequence Number: 1
• Product Code: MBH
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K141056
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,other
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 10/20/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/16/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 07/31/2016
• Device Catalogue Number: 5526B600
• Device Lot Number: S4T6Y
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 03/12/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/18/2011
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 59 YR