MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH SECUR-FIT HA PSL CUP/CLUSTR SHELL 46MM; HIP JOINT METAL/CERAMIC/POLYMER SEMI-CONSTRAINED CEMENTED OR NONPOROUS UNCEMENTE

Catalog Number	2051-2046
Medical Device Problem Codes	Malposition of Device (2616); Positioning Problem (3009)
Health Effect - Clinical Code	Injury (2348)
Date of Event	02/15/2010
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
An event regarding poly wear involving a securfit shell was reported.A clinical review confirmed the event.Device evaluation and results: a visual, dimensional, functional and material analysis inspection was not performed as the device was not returned for evaluation.Medical records received and evaluation: a review of the provided medical records and x-rays by a clinical consultant indicated: "the description of the acetabular component as "more vertical than normal" would suggest an inherently unstable hip that, after some poly wear, dislocated.It was noted on (b)(6) 2001 (four months status-post primary total hip) that the hip was popping in and out of place.The first revision done, in which a constrained liner was not available in the operating room, resulted in persistent instability causing the subsequent revision to a constrained liner two months later.During this surgery inherent instability of a 10° constrained liner further suggests the malposition of the acetabular shell.There is no evidence that factors of faulty prosthetic design, manufacturing, or materials were responsible for this clinical situation." device history review: all devices in the reported lot were manufactured and accepted into final stock with no relevant reported discrepancies.Complaint history review: there has been one other event for the lot referenced, however, it is for the same patient.A medical review confirmed that the wear of the liner is a result of the shell positioning as noted "more vertical than normal" and "during this surgery inherent instability of a 10° constrained liner further suggests the malposition of the acetabular shell".No further investigation is required at this time.If additional relevant information becomes available, this investigation will be reopened.Not returned.
Event or Problem Description
Per medical review: "on (b)(6) 2010 a revision of the right total hip arthroplasty with exchange of the poly insert and femoral head was performed for a diagnosis of poly wear right hip." medical review notes operative report dated (b)(6) 2010 states: "acetabulum may be a little more vertical than normal".

• Brand Name: SECUR-FIT HA PSL CUP/CLUSTR SHELL 46MM
• Common Device Name: HIP JOINT METAL/CERAMIC/POLYMER SEMI-CONSTRAINED CEMENTED OR NONPOROUS UNCEMENTE
• Manufacturer (Section D): STRYKER ORTHOPAEDICS-MAHWAH; 325 corporate drive; mahwah NJ 07430
• MDR Report Key: 7903852
• Report Number: 0002249697-2018-03019
• Device Sequence Number: 18873978
• Product Code: MEH
• UDI-Device Identifier: 07613327020281
• UDI-Public: 07613327020281
• Combination Product (Y/N): N
• Initial Reporter State: MO
• Initial Reporter Country: US
• PMA/510(K) Number: K942900
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Explanted Year: 2010
• Reporter Type: Manufacturer
• Report Source: consumer,other
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 09/24/2018

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 Catalogue Number: 2051-2046
• Device Lot Number: 53099801
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/28/2018
• Initial Report FDA Received Date: 09/24/2018
• 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: 54 YR
• Patient Weight: 62