MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH SECUR-FIT HA PSL CUP/CLUSTR SHELL 46MM; PROSTHESIS, HIP, SEMI-CONSTRAINED, UNCEMENTED, METAL/POLYMER, NON-POROUS, CALICU

Catalog Number	2051-2046
Medical Device Problem Code	Malposition of Device (2616)
Health Effect - Clinical Codes	Injury (2348); Joint Dislocation (2374)
Date of Event	04/14/2010
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Review of the product history records indicates devices were manufactured and accepted into final stock with no reported discrepancies.There have been no other similar events for the lot referenced.No x-rays are available for review and there is no examination of explanted components.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.The information in this report was provided by stryker orthopaedics legal affairs department.No additional information is available at this time due to the ongoing litigation.Should additional information become available, the evaluation summary will be submitted in a supplemental report.Not returned to the manufacturer.
Event or Problem Description
It was reported through a filed lawsuit, that allegedly, "the sales personnel failed to bring the proper insert to surgery (a constrained insert) and the patient allegedly thereafter suffered dislocation and had to ultimately go back to surgery and have the constrained liner implanted." this pi to cover revision on (b)(6) 2010 for alleged instability as a result of a constrained liner not available at time of previous revision on (b)(6) 2010.Per medical review: "on (b)(6) 2010 a revision of the right total hip arthroplasty to a constrained liner was performed for a diagnosis of unstable right total hip arthroplasty.The operative report states, "acetabulum may be a little more vertical than normal.".

• Brand Name: SECUR-FIT HA PSL CUP/CLUSTR SHELL 46MM
• Common Device Name: PROSTHESIS, HIP, SEMI-CONSTRAINED, UNCEMENTED, METAL/POLYMER, NON-POROUS, CALICU
• Manufacturer (Section D): STRYKER ORTHOPAEDICS-MAHWAH; 325 corporate drive; mahwah NJ 07430
• MDR Report Key: 7910009
• Report Number: 0002249697-2018-03040
• Device Sequence Number: 11099504
• 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): 09/26/2018

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: 04/30/2005
• 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: 09/26/2018
• 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