MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH CENTRAX DURATION 26MM X 45MM; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, CEMENTED

Catalog Number	6226-2-645
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Codes	Injury (2348); Reaction (2414)
Date of Event	04/10/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Review of the device history records indicate devices were manufactured and accepted into final stock with no relevant reported discrepancies.There have been no other similar events for the lot referenced.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 explanting of bipolar was performed due to the suspicion of metal allergy.A large amount of lumpy tissue emerged from the hip of the patient.The customer would like to know the amount of polyethylene wear.
Event or Problem Description
The explanting of bipolar was performed due to the suspicion of metal allergy.A large amount of lumpy tissue emerged from the hip of the patient.The customer would like to know the amount of polyethylene wear.Event update per review of the clinician's comment: rejected for medical review - spacer noted on x-ray indicates infection, however, cannot confirm infection or reported event.
Additional Manufacturer Narrative
An event regarding infection/ allergy/reaction involving an uhr head was reported.The event was not confirmed.Method & results: -product evaluation and results: visual inspection was performed as part of the material analysis report (mar), dated 26 june 2019, this inspection indicated: nothing noteworthy was observed on the centrax prosthesis.Material evaluation was completed and indicated the following comments: the damage observed on the inner taper of the head was consistent with contact against the hip stem trunnion.Eds showed the stem was consistent with an astm f136 alloy and the head and centrax prosthesis were consistent with an astm f75 alloy.Based on the given information, no identifiable materials or manufacturing discrepancies were observed on the surfaces examined.-clinician review: a review of the provided medical records by a clinical consultant stated the following comment: spacer noted on x-ray indicates infection, however, cannot confirm infection or reported event, need operative reports, clinical and past medical history and pathology reports.-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 or sterile lot referenced.Conclusion: visual inspection was performed as part of the material analysis report (mar), dated 26 june 2019, this inspection indicated: nothing noteworthy was observed on the centrax prosthesis.Material evaluation was completed and indicated the following comments: the damage observed on the inner taper of the head was consistent with contact against the hip stem trunnion.Eds showed the stem was consistent with an astm f136 alloy and the head and centrax prosthesis were consistent with an astm f75 alloy.Based on the given information, no identifiable materials or manufacturing discrepancies were observed on the surfaces examined.The event itself could not be confirmed and exact cause of the event could not be determined because insufficient information was provided.Further information such as operative reports, clinical and past medical history and pathology reports are required to complete the investigation for determining a root cause.No further investigation is required at this time.If additional information becomes available to indicate further evaluation is warranted, this record will be reopened.

• Brand Name: CENTRAX DURATION 26MM X 45MM
• Common Device Name: PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, CEMENTED
• Manufacturer (Section D): STRYKER ORTHOPAEDICS-MAHWAH; 325 corporate drive; mahwah NJ 07430
• MDR Report Key: 8592064
• Report Number: 0002249697-2019-01877
• Device Sequence Number: 13948585
• Product Code: JDI
• UDI-Device Identifier: 07613327032192
• UDI-Public: 07613327032192
• Combination Product (Y/N): N
• PMA/510(K) Number: K972792
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: health professional,other
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 08/06/2019

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: 04/30/2021
• Device Catalogue Number: 6226-2-645
• Device Lot Number: ER86TA
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/06/2019
• Initial Date Received by Manufacturer: 04/10/2019
• Supplement Date Received by Manufacturer: 07/09/2019
• Initial Report FDA Received Date: 05/08/2019
• Supplement Report FDA Received Date: 08/06/2019
• 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: 58 YR
• Patient Weight: 54