MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH SECUR-FIT MAX 132 HIP STEM #9; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/CERAMIC/POLYMER, CEMENTED OR NON-POROUS

Model Number	6051-0935S
Medical Device Problem Code	Osseointegration Problem (3003)
Health Effect - Clinical Codes	Pain (1994); Inadequate Osseointegration (2646)
Date of Event	05/24/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Reported event: an event regarding loosening and pain involving a securfit stem was reported.The event was not confirmed.Method & results: product evaluation and results: the reported device was not returned; however, photographs were provided for review.The photographs show a recently explanted stem which is covered in blood.From the photographs provided there is no evidence the device contributed to the reported event.Clinician review: no medical records were received for review with a clinical consultant.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's right hip was revised due to pain and suspected stem loosening.The exact cause of the event could not be determined because insufficient information was provided.Further information such as return of the device, 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 devices and/or additional information become available to indicate further evaluation is warranted, this record will be reopened.The following devices were also listed in this report: device name#36 +5 biolox c-taper head; cat#18-3605; lot#unknown; device name#36e 0° liner; cat#unknown; lot#unknown.It cannot be determined which, if any of these devices may have caused or contributed to the patient's experience.H3 other text : device not returned to the manufacturer.
Event or Problem Description
It was reported that the patient's right hip was revised due to pain and suspected stem loosening (loosening was neither confirmed nor denied by the surgeon intra-operatively).A stem, head, and liner were revised to a restoration modular stem construct, femoral head, adm/ mdm poly insert, and mdm metal liner.

• Brand Name: SECUR-FIT MAX 132 HIP STEM #9
• Common Device Name: PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/CERAMIC/POLYMER, CEMENTED OR NON-POROUS
• Manufacturer (Section D): STRYKER ORTHOPAEDICS-MAHWAH; 325 corporate drive; mahwah NJ 07430
• Manufacturer (Section G): STRYKER ORTHOPAEDICS-MAHWAH; 325 corporate drive; mahwah NJ 07430
• Manufacturer Contact: arokiya raj ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 17141499
• Report Number: 0002249697-2023-00683
• Device Sequence Number: 7826048
• Product Code: LZO
• UDI-Device Identifier: 07613327021035
• UDI-Public: 07613327021035
• Combination Product (Y/N): N
• Initial Reporter State: MI
• Initial Reporter Country: US
• PMA/510(K) Number: K041170
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2014
• Device Explanted Year: 2023
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 06/16/2023

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: 02/28/2019
• Device Model Number: 6051-0935S
• Device Catalogue Number: 6051-0935S
• Device Lot Number: MMT0LX
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 05/24/2023
• Initial Report FDA Received Date: 06/16/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 02/10/2014
• 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 Age: 81 YR
• Patient Sex: Male