MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH PRIMARY TRITANIUM HEMI CLUSTER HOLE CUP 52MM; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED

Model Number	502-03-52D
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	03/23/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Reported event: an event regarding revision for revision involving a trident shell was reported.The event was not confirmed.Method & results:  device evaluation and results: not performed as product was not returned.  clinician review:  a review of the provided medical records and x-rays by a clinical consultant indicated.Event description: dr.Revised a cup, liner and head due to dislocation.Original surgery was done on (b)(6) 2016.Dr.Revised to an mdm.Operative side: right.Implants involved: delta c-taper head 36 +0mm, primary tritanium hemi cluster hole cup 52mm documents reviewed.03/23/2021: stryker pi report.Undated/unlabeled ap hip x-ray: secure fit style stem, with vertically oriented cup.(b)(6) 2016: operative note: primary tha right (52mm tritanium shell, #8 secure fit max stem 1270, 36mm biolox head, posterior approach, underreamed by 1mm, 36mm head event confirmation: the event cannot be confirmed.The only evidence of a complication was the pi report.Root cause: assuming the event did occur, i.E.Hip instability with dislocation, the likely root cause would be the implant position.The cup is extremely vertical.   device history review: indicate 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 lot referenced.Conclusion: 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 the reason for the revision surgery, device return, pre and post operative x-rays, operative reports as well as patient history and follow up notes 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.
Event or Problem Description
Dr.Revised a cup, liner and head due to dislocation.Original surgery was done on (b)(6) 2021.Dr.Revised to an mdm.Operative side: right.

• Brand Name: PRIMARY TRITANIUM HEMI CLUSTER HOLE CUP 52MM
• 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: 11677496
• Report Number: 0002249697-2021-00693
• Device Sequence Number: 3511536
• Product Code: LPH
• UDI-Device Identifier: 07613327040128
• UDI-Public: 07613327040128
• Combination Product (Y/N): N
• Initial Reporter State: RI
• Initial Reporter Country: US
• PMA/510(K) Number: K143085
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• Device Explanted Year: 2021
• Reporter Type: Manufacturer
• Report Source: health professional,other
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 04/16/2021

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: 08/31/2021
• Device Model Number: 502-03-52D
• Device Catalogue Number: 502-03-52D
• Device Lot Number: 5M4TRV
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/23/2021
• Initial Report FDA Received Date: 04/16/2021
• 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: 74 YR