MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH SECUR-FIT MAX 127 HIP STEM #9; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/CERAMIC/POLYMER, CEMENTED OR NON-POROUS

Catalog Number 6052-0935S

Device Problem Loss of Osseointegration (2408)

Patient Problems Injury (2348); Joint Dislocation (2374); Inadequate Osseointegration (2646)

Event Date 06/03/2018

Event Type  Injury  

Manufacturer Narrative

Review of the device history records indicate (b)(4) devices were manufactured and accepted into final stock on 8 november, 2017 with no relevant reported discrepancies.There have been no other similar events for the lot referenced.It was noted that the device is not available for evaluation.If additional information is received, it will be provided in a supplemental report upon completion of the investigation.Not returned.

Event Description

Pt dislocated while walking.Revision was done.All components replaced.Rep.Confirmed dislocation - head dislocated from liner.Revision construct included an adm/mdm liner construct.Per rep, regarding revision of stem and cup."everything was loose and needed to be upsized.".

• Brand Name: SECUR-FIT MAX 127 HIP STEM #9
• Type of Device: 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: brad curtis ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 7645961
• MDR Text Key: 112592606
• Report Number: 0002249697-2018-01989
• Device Sequence Number: 1
• Product Code: LZO
• UDI-Device Identifier: 07613327021127
• UDI-Public: 07613327021127
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K051738
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,other
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 06/28/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/28/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 11/30/2022
• Device Catalogue Number: 6052-0935S
• Device Lot Number: P40JLH
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/03/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/07/2017
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 75 YR