MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH CITATION TMZF HA STEM #4 LEFT; HIP JOINT METAL/POLYMER/METAL SEMI-CONSTRAINED POROUS-COATED UNCEMENTED PROSTHES

Catalog Number	6265-5104
Medical Device Problem Code	Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	Injury (2348)
Date of Event	07/19/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
A supplemental report will be submitted upon completion of the investigation.
Event or Problem Description
Patient presented to dr.(b)(6) on (b)(6), and he revised the hip stem, head and liner on (b)(6).Update: per operative report, "left hip failed total hip arthroplasty.He was getting out of a chair when he felt a sudden change had a significant pain.Was noted to have dissociation of the femoral head and the stem.The abductors were in good shape.There was no true pseudotumor outside of the joint.There was a gush of fluid with the typical brownish dark color consistent with some metal reaction.There was some surrounding adverse local tissue reaction among the capsule and extending anteriorly.The head was obviously off the stem, it was very evident that the trunnion had significant damage to it.".
Additional Manufacturer Narrative
Update to implant date.An event regarding altr (adverse local tissue reaction) involving a citation stem was reported.The event was confirmed through clinician review of the provided medical records.Method & results: -product evaluation and results: visual inspection was performed as part of the material analysis report (mar), dated 31 january 2019 which indicated: damages were observed on the neck of the stem, consistent with wear mechanisms due to the cyclic contact between the head taper and stem trunnion.Damage consistent with the explantation process in addition to biological fixation were also observed on the stem.A material analysis has been performed.The report concluded: damage was observed on the stem trunnion and head taper.This damage was consistent with wear mechanisms due to the cyclic contact between the head taper and stem trunnion.Debris was also observed on the head.Damage consistent with impingement and the explantation process was observed on the insert.Scratching was also observed on the insert, which is a common damage mode of uhmwpe.Yellow discoloration consistent with absorption of synovial fluid was also observed on the insert.Debris was also observed on the insert.Eds showed the stem was consistent with astm fl 813 alloy, the head was consistent with astm f1537 alloy, the debris from the head was consistent with a corrosion product, stem base alloy and biological material and the debris from the insert was consistent with the stem base alloy.-clinician review: a review of the provided medical records by a clinical consultant indicated: on (b)(6) 2018 a revision of the left well-fixed femoral component, an acetabular liner change, and soft tissue and metalosis debridement was performed for a pre- and post­ operative diagnosis of failed left total hip with disassociation femoral head.With trunnion wear, mild metalosis reactant, deformity to acetabular liner" [.] no true pseudotumor.Agush of fluid.Brownish dark color consistent with some metal reaction.Some surrounding adverse local tissue reaction.Extending anteriorly.Head was off the stem.Trunnion had significant damage.With osteotomes.Stem well-fixed.No x-rays are available for review until prior to the revision surgery twelve years after the primary total hip arthroplasty.No clinical problems were documented in this large, male.Patient until several weeks prior to the revision for disassociation.Based upon the material.Available for review, no determination can be made regarding the reported event.-product 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: visual inspection was performed as part of the material analysis report (mar), dated 31 january 2019 which indicated: damages were observed on the neck of the stem, consistent with wear mechanisms due to the cyclic contact between the head taper and stem trunnion.Damage consistent with the explantation process in addition to biological fixation were also observed on the stem.A material analysis has been performed.The report concluded: damage was observed on the stem trunnion and head taper.This damage was consistent with wear mechanisms due to the cyclic contact between the head taper and stem trunnion.Debris was also observed on the head.Damage consistent with impingement and the explantation process was observed on the insert.Scratching was also observed on the insert, which is a common damage mode of uhmwpe.Yellow discoloration consistent with absorption of synovial fluid was also observed on the insert.Debris was also observed on the insert.Eds showed the stem was consistent with astm fl 813 alloy, the head was consistent with astm f1537 alloy, the debris from the head was consistent with a corrosion product, stem base alloy and biological material and the debris from the insert was consistent with the stem base alloy.A review of the provided medical records by a clinical consultant indicated: on (b)(6) 2018 a revision of the left well-fixed femoral component, an acetabular liner change, and soft tissue and metalosis debridement was performed for a pre- and post­ operative diagnosis of failed left total hip with disassociation femoral head.With trunnion wear, mild metalosis reactant, deformity to acetabular liner" [.] no true pseudotumor.Agush of fluid.Brownish dark color consistent with some metal reaction.Some surrounding adverse local tissue reaction.Extending anteriorly.Head was off the stem.Trunnion had significant damage.With osteotomes.Stem well-fixed.No x-rays are available for review until prior to the revision surgery twelve years after the primary total hip arthroplasty.No clinical problems were documented in this large, male patient until several weeks prior to the revision for disassociation.Based upon the material available for review, no determination can be made regarding the reported event.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 or Problem Description
Patient presented to dr.On july 17, and revised the hip stem, head and liner on july 19.Update: per operative report, "left hip failed total hip arthroplasty.He was getting out of a chair when he felt a sudden change had a significant pain.Was noted to have dissociation of the femoral head and the stem.The abductors were in good shape.There was no true pseudotumor outside of the joint.There was a gush of fluid with the typical brownish dark color consistent with some metal reaction.There was some surrounding adverse local tissue reaction among the capsule and extending anteriorly.The head was obviously off the stem, it was very evident that the trunnion had significant damage to it.".

• Brand Name: CITATION TMZF HA STEM #4 LEFT
• Common Device Name: HIP JOINT METAL/POLYMER/METAL SEMI-CONSTRAINED POROUS-COATED UNCEMENTED PROSTHES
• Manufacturer (Section D): STRYKER ORTHOPAEDICS-MAHWAH; 325 corporate drive; mahwah NJ 07430
• MDR Report Key: 8073663
• Report Number: 0002249697-2018-03730
• Device Sequence Number: 2165564
• Product Code: LPH
• UDI-Device Identifier: 07613153074274
• UDI-Public: 07613153074274
• Combination Product (Y/N): N
• Initial Reporter State: IN
• Initial Reporter Country: US
• PMA/510(K) Number: K121308
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2006
• Device Explanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: health professional,other
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 07/01/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Expiration Date: 04/30/2011
• Device Catalogue Number: 6265-5104
• Device Lot Number: 17504401
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/19/2018
• Initial Date Received by Manufacturer: 10/18/2018
• Supplement Date Received by Manufacturer: 06/05/2019
• Initial Report FDA Received Date: 11/15/2018
• Supplement Report FDA Received Date: 07/01/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Age: 71 YR
• Patient Weight: 100