MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH SUPER SECUR-FIT 127 DEGREE SIZE 8; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED

Catalog Number	J6052-0830
Medical Device Problem Codes	Fracture (1260); Loss of Osseointegration (2408); Osseointegration Problem (3003)
Health Effect - Clinical Codes	Injury (2348); Inadequate Osseointegration (2646)
Date of Event	08/27/2019
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.If additional information is received, it will be provided in a supplemental report upon completion of the investigation.The event involves a device that is not cleared for sale in the u.S., but similar device is commercially available in the u.S.
Event or Problem Description
On (b)(6) 2009: resurfacing head (181142/mmt) and metal on metal cup 48mm cup for 42mm head (172485/ mmt) was implanted.On (b)(6) 2010: the femoral neck fracture was occurred and tha was done with ssf stem and modular head v40 taper 42mm -4mm neck length (179-242/mmt).On (b)(6) 2019: revision surgery of all devices were done because the loosening and armd was occurred.
Event or Problem Description
2009.Sep.16: resurfacing head(181142/mmt) and metal on metal cup 48mm cup for 42mm head( 172485/ mmt) was implanted.2010.Feb.15: the femoral neck fracture was occurred and tha was done with ssf stem and modular head v40 taper 42mm -4mm neck length (179-242/mmt).2019.8.29: revision surgery of all devices were done because the loosening and armd was occurred.Update: "cup was loose." right side.
Additional Manufacturer Narrative
An event regarding altr involving a securfit stem was reported.The event was not confirmed.Method & results: -product evaluation and results: visual inspection was performed as part of the material evaluation and indicated the following comments: damage consistent with the implantation/explantation process was observed on the stem.Biological material was also observed on the coated region of the stem.Eds on the debris collected form the stem was consistent with an oxide, a corrosion product, and biological material.Based on the given information, no identifiable materials or manufacturing discrepancies were observed on the surfaces examined.-medical records received and evaluation: not performed as no medical records were returned for review.-product history review: a review of the device manufacturing records indicate that all devices accepted into final stock were free from discrepancies.-complaint history review: there were no other events for the lot provided.Conclusions: the exact cause of the event could not be determined because insufficient information was provided.Further information such as pathology reports, pre- and post-operative x-rays and the primary operative report as well as patient history and follow-up notes are needed to complete the investigation for determining root cause.No further investigation for this event is possible at this time as no devices and insufficient information was received by stryker orthopaedics.If devices and / or additional information become available to indicate further evaluation is warranted, this record will be reopened.

• Brand Name: SUPER SECUR-FIT 127 DEGREE SIZE 8
• 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: 9109430
• Report Number: 0002249697-2019-03314
• Device Sequence Number: 19729795
• Product Code: LPH
• UDI-Device Identifier: 07613327101768
• UDI-Public: 07613327101768
• Combination Product (Y/N): N
• PMA/510(K) Number: K121308
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2010
• 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): 11/12/2019

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: 08/31/2014
• Device Catalogue Number: J6052-0830
• Device Lot Number: 30570601
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/10/2019
• Initial Date Received by Manufacturer: 08/27/2019
• Supplement Date Received by Manufacturer: 10/15/2019
• Initial Report FDA Received Date: 09/24/2019
• Supplement Report FDA Received Date: 11/12/2019
• 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