MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH PRIMARY TRITANIUM HEMI CLUSTER HOLE CUP 60MM; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED

Catalog Number	502-03-60F
Medical Device Problem Code	Unstable (1667)
Health Effect - Clinical Codes	Injury (2348); Ambulation or Postural Difficulties (2544)
Date of Event	10/31/2019
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.An evaluation of the device cannot be performed as the device was not returned to the manufacturer.Should additional information become available it will be reported in a supplemental report upon completion of the investigation.Not returned to the manufacturer.
Event or Problem Description
Second stage revision of tritanium primary cluster cup with adm & exeter.All components revised due to instability & head/adm insert disassociation.I filed another pi on his same patient one week ago when it was discovered this patient had already been revised on the (b)(6) 2019, again due to disassociation of head with adm insert.Update (b)(6) 2019 wg: sales rep reported that the tritanium primary shell and exeter stem were also revised.
Additional Manufacturer Narrative
An event regarding instability involving a trident shell was reported.The event was confirmed by medical review.Method & results: device evaluation and results: the shell was returned with the mdm liner still seated within it.There is evidence of bone in-growth on fixation surface of the shell but otherwise the device appears unremarkable.Clinician review: a review of the provided medical records and/or x-rays by a clinical consultant indicated: the persistent instability of the right total hip arthroplasty since the original surgery for a fractured femoral neck suggests impingement at the extremes of motion and/or malposition of one or both hip components.No imaging studies available, including a lateral, can confirm the version of the components.There is no evidence this clinical situation was related to factors associated with implant design, manufacturing or materials.Device history review indicated the devices accepted into final stock from the reported lot were free from discrepancies.Complaint history review: there have been no other similar events for the reported lot.Conclusion: the exact cause of the event could not be determined because insufficient information was provided.Additional information including imaging studies, including a lateral, are needed to fully investigate the event.If additional information become available to indicate further evaluation is warranted, this record will be reopened.
Event or Problem Description
Second stage revision of tritanium primary cluster cup with adm & exeter.All components revised due to instability & head/adm insert disassociation.I filed another pi on his same patient one week ago when it was discovered this patient had already been revised on (b)(6) 2019, again due to disassociation of head with adm insert.Update 04/november/2019 wg: sales rep reported that the tritanium primary shell and exeter stem were also revised.

• Brand Name: PRIMARY TRITANIUM HEMI CLUSTER HOLE CUP 60MM
• 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: 9383075
• Report Number: 0002249697-2019-03883
• Device Sequence Number: 10882548
• Product Code: LPH
• UDI-Device Identifier: 07613327040173
• UDI-Public: 07613327040173
• Combination Product (Y/N): N
• Initial Reporter Country: AU
• PMA/510(K) Number: K143085
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• 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): 01/17/2020

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: 11/30/2021
• Device Catalogue Number: 502-03-60F
• Device Lot Number: WY28E2
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/06/2019
• Initial Date Received by Manufacturer: 10/31/2019
• Supplement Date Received by Manufacturer: 12/19/2019
• Initial Report FDA Received Date: 11/27/2019
• Supplement Report FDA Received Date: 01/17/2020
• 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 Age: 68 YR
• Patient Weight: 69