MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH PRIMARY TRITANIUM HEMI CLUSTER HOLE CUP 58MM; HIP JOINT METAL/POLYMER/METAL SEMI-CONSTRAINED POROUS-COATED UNCEMENTED PROSTHES

Catalog Number	502-03-58F
Medical Device Problem Codes	Malposition of Device (2616); Positioning Problem (3009)
Health Effect - Clinical Code	Injury (2348)
Date of Event	07/24/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
A review of the device history records indicates that the reported devices were manufactured and accepted into final stock with no reported discrepancies.The complaint history review indicated that there were no similar events for the reported lot.If additional information is received, it will be provided in a supplemental report upon completion of the investigation.
Event or Problem Description
Patient was getting off the toilet and felt hip become unstable.She presented to (b)(6)hospital with a dislocated hip.The bipolar head from the constrained liner had disengaged from the outer component.On (b)(6) 2018, dr.(b)(6) performed an open reduction, where the liner was revised.The patient had their cup previously revised for recurrent dislocation in (b)(6) 2017.When dr (b)(6) performed an open reduction on (b)(6) 2018, he commented that the cup wasn¿t anteverted as it should have been.
Additional Manufacturer Narrative
An event regarding disassociation involving a trident liner was reported.Malposition of the trident shell was confirmed as a result of a medical review.Method & results: device evaluation and results: not performed as the reported device was not returned for evaluation.Medical records received and evaluation: a review of the provided medical records noted ; review of these records confirms dissociation of a constrained liner from an acetabular shell occurred.X-rays demonstrate that the acetabular component was position in near neutral anteversion which is a risk factor for instability, however, the root cause cannot be determined as insufficient information was available.Device history review: review indicated all devices were manufactured and accepted into final stock with no reported discrepancies.Complaint history review: review indicated there have been no other similar events for the reported lot.Conclusion: a medical review confirmed malposition of the trident shell.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 was getting off the toilet and felt hip become unstable.She presented to concord hospital with a dislocated hip.The bipolar head from the constrained liner had disengaged from the outer component.On(b)(6) 2018 , dr.(b)(6).Performed an open reduction, where the liner was revised.The patient had their cup previously revised for recurrent dislocation in (b)(6) 2017.When dr.(b)(6) performed an open reduction on (b)(6) 2018 , he commented that the cup wasn¿t anteverted as it should have been.

• Brand Name: PRIMARY TRITANIUM HEMI CLUSTER HOLE CUP 58MM
• 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: 7801785
• Report Number: 0002249697-2018-02617
• Device Sequence Number: 1909194
• Product Code: LPH
• UDI-Device Identifier: 07613327040159
• UDI-Public: 07613327040159
• 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: 2017
• 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): 11/21/2018

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: 07/31/2021
• Device Catalogue Number: 502-03-58F
• Device Lot Number: 56208901
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 07/24/2018
• Supplement Date Received by Manufacturer: 10/26/2018
• Initial Report FDA Received Date: 08/21/2018
• Supplement Report FDA Received Date: 11/21/2018
• 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: 75 YR