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

Model Number	J6051-0625
Medical Device Problem Codes	Degraded (1153); Loss of Osseointegration (2408)
Health Effect - Clinical Code	Osteolysis (2377)
Date of Event	08/19/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
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.
Event or Problem Description
Preoperative ct showed halos as if the ceramic liner was cracked.It was removed and checked, but it was not cracked.Since the osteosteolysis in the proximal femur was large even though it was ceramic on ceramic, surgeon asked to investigate if there was any invisible wear.
Event or Problem Description
Preoperative ct showed halos as if the ceramic liner was cracked.It was removed and checked, but it was not cracked.Since the osteosteolysis in the proximal femur was large even though it was ceramic on ceramic, surgeon asked to investigate if there was any invisible wear.
Additional Manufacturer Narrative
Reported event: an event regarding wear/osteolysis involving a securfit stem was reported.The event was not confirmed.Method & results: -product evaluation and results: visual inspection: visual inspection was performed as part of the material analysis: "optical microscopy with magnifications up to 50x were used in this portion of the investigation.The proximal and distal surfaces of the alumina ceramic v40 head, respectively, with minor scratches/material surface marks observed.The distal surface of the shell & liner assembly intact.The proximal surface of the titanium alloy shell with the liner visible through the center hole.The side of the stem showing explantation damage.Higher magnification images of the stem trunnion and neck respectively." material analysis: a material analysis was performed and concluded the following: "material surface marks were observed on both the proximal and distal sides of the alumina head.The surface marks were from an unknown source, possibly a result of explantation.No manufacturing related defects were observed on the device surfaces examined." -clinician review: insufficient information was provided to support a medical review.-product history review: review of the device history records indicate devices were manufactured and accepted into final stock with no relevant reported discrepancies.-complaint history review: there have been no other similar events for the lot referenced.Conclusions: it was reported that the patient was revised due to osteolysis and wear of devices was suspected.Visual inspection was performed as part of the material analysis: "optical microscopy with magnifications up to 50x were used in this portion of the investigation.The proximal and distal surfaces of the alumina ceramic v40 head, respectively, with minor scratches/material surface marks observed.The distal surface of the shell & liner assembly intact.The proximal surface of the titanium alloy shell with the liner visible through the center hole.The stem showing explantation damage.Higher magnification images of the stem trunnion and neck respectively." the material analysis concluded the following: "material surface marks were observed on both the proximal and distal sides of the alumina head.The surface marks were from an unknown source, possibly a result of explantation.No manufacturing related defects were observed on the device surfaces examined." 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 revision 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.If additional information becomes available to indicate further evaluation is warranted, this record will be reopened.

• Brand Name: SUPER SECUR FIT
• Common Device Name: PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED
• Manufacturer (Section D): STRYKER ORTHOPAEDICS-MAHWAH; 325 corporate drive; mahwah NJ 07430
• Manufacturer (Section G): STRYKER ORTHOPAEDICS-CORK; ida industrial estate; carrigtwohill NA ; EI NA
• Manufacturer Contact: marisol santiago ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 12467157
• Report Number: 0002249697-2021-01559
• Device Sequence Number: 19788751
• Product Code: LPH
• UDI-Device Identifier: 04546540002891
• UDI-Public: 04546540002891
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K121308
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2008
• Device Explanted Year: 2021
• Reporter Type: Manufacturer
• Report Source: Other,Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 12/13/2022

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: 02/29/2012
• Device Model Number: J6051-0625
• Device Catalogue Number: J6051-0625
• Device Lot Number: 21057401
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 08/19/2021
• Supplement Date Received by Manufacturer: 11/22/2022
• Initial Report FDA Received Date: 09/14/2021
• Supplement Report FDA Received Date: 12/13/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 02/02/2007
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Sex: Female