MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH PRIMARY TRITANIUM HEMI CLUSTER HOLE CUP 46MM; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED

Model Number	502-03-46B
Medical Device Problem Code	Loss of Osseointegration (2408)
Health Effect - Clinical Codes	Injury (2348); Inadequate Osseointegration (2646)
Date of Event	04/02/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
It was noted that the device is not available for evaluation.Should additional information become available, it will be provided in a supplemental report upon completion of the investigation.
Event or Problem Description
The replacement was performed due to the looseness of the tritanium cup.Our products are only explantation.One year after the operation, the doctor asked me, "isn't bone tissue ingrown in the cup?" he wanted an investigation report including the cause of the loosening.Regarding accolade ii, it was difficult to remove it, so he acknowledged the fixation, but he also wanted a report.Update: left side.Stem was also removed and replaced, as the cup was loose.
Additional Manufacturer Narrative
Visual inspection updated.Manuf & exp dated added.Reported event: an event regarding loosening involving trident shell was reported.The event was not confirmed.Method & results: device evaluation and results: visual inspection.Visual inspection was performed as part of the material analysis report (mar), dated 08-sep-2020.This inspection indicated damage consistent with the explantation process was observed on the distal surface of the cup.Biological material was observed on the porous surface of the cup, the biological material was examined further using a scanning electron microscope.Dimensional inspection: not performed as the dimensional aspects are not in question.Functional inspection: not performed as the functional aspects are not in question.Material analysis: a material analysis has been performed.The report concluded: damage consistent with the explantation process was observed on the tritanium cup,trident insert, and the accolade ii stem.Biological material was observed on the porous surface of the cup and stem.The impression markings on the insert were consistent with contact against screws used to secure the tritanium cup.Damage on two of the three screws was consistent with driving torque during implantation process.Damage on the articulating surface of the insert was consistent with scratching and third body indentations which are common damage modes of uhmwpe.A continuous metal transfer ring was observed at the proximal end of the ceramic head taper.The stem and cup were consistent with astm f136 alloys and the porous coatings were consistent with astm f67; which is consistent with their respective drawings.The debris collected is morphologically consistent with the tritanium porous coating from either the stem or cup.Biological material consistent with bone was observed in the pores of the titanium coating.Based on the given information, no identifiable materials or manufacturing discrepancies were observed on the surfaces examined.-clinician review: no medical records were received for review with a clinical consultant.-device history review: all devices were manufactured and accepted into final stock with no relevant reported discrepancies.-complaint history review: there have been no other similar events for the reported lot.Conclusion: it was reported that the replacement was performed due to the looseness of the tritanium cup.The event was not confirmed.Visual inspection was performed as part of the material analysis report (mar), dated 08-sep-2020.This inspection indicated damage consistent with the explantation process was observed on the distal surface of the cup.Biological material was observed on the porous surface of the cup, the biological material was examined further using a scanning electron microscope.A material analysis has been performed.The report concluded: damage consistent with the explantation process was observed on the tritanium cup,trident insert, and the accolade ii stem.Biological material was observed on the porous surface of the cup and stem.The impression markings on the insert were consistent with contact against screws used to secure the tritanium cup.Damage on two of the three screws was consistent with driving torque during implantation process.Damage on the articulating surface of the insert was consistent with scratching and third body indentations which are common damage modes of uhmwpe.A continuous metal transfer ring was observed at the proximal end of the ceramic head taper.The stem and cup were consistent with astm f136 alloys and the porous coatings were consistent with astm f67; which is consistent with their respective drawings.The debris collected is morphologically consistent with the tritanium porous coating from either the stem or cup.Biological material consistent with bone was observed in the pores of the titanium coating.Based on the given information, no identifiable materials or manufacturing discrepancies were observed on the surfaces examined.The exact cause of the event could not be determined because insufficient information was provided.Additional information including operative reports, progress notes, x-rays are needed to fully investigate the event.If further information becomes available this investigation will be re-opened.
Event or Problem Description
The replacement was performed due to the looseness of the tritanium cup.Our products are only explantation.One year after the operation, the doctor asked me, "isn't bone tissue ingrown in the cup?" he wanted an investigation report including the cause of the loosening.Regarding accolade ii, it was difficult to remove it, so he acknowledged the fixation, but he also wanted a report.Update: left side.Stem was also removed and replaced, as the cup was loose.

• Brand Name: PRIMARY TRITANIUM HEMI CLUSTER HOLE CUP 46MM
• Common Device Name: PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED
• Manufacturer (Section D): STRYKER ORTHOPAEDICS-MAHWAH; 325 corporate drive; mahwah NJ 07430
• MDR Report Key: 10017025
• Report Number: 0002249697-2020-00848
• Device Sequence Number: 16969953
• Product Code: LPH
• UDI-Device Identifier: 07613327040104
• UDI-Public: 07613327040104
• Combination Product (Y/N): N
• PMA/510(K) Number: K143085
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Device Explanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: health professional,other
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 11/03/2020

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: 08/31/2023
• Device Model Number: 502-03-46B
• Device Catalogue Number: 502-03-46B
• Device Lot Number: 945WH6
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/03/2020
• Initial Date Received by Manufacturer: 04/03/2020
• Supplement Date Received by Manufacturer: 09/11/2020
• Initial Report FDA Received Date: 05/01/2020
• Supplement Report FDA Received Date: 11/03/2020
• 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 Weight: 78