MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH SECUR-FIT MAX 127 HIP STEM #8; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/CERAMIC/POLYMER, CEMENTED OR NON-POROU

Catalog Number 6052-0830S

Device Problems Degraded (1153); Device Damaged by Another Device (2915); Material Deformation (2976); Insufficient Information (3190)

Patient Problems Unspecified Infection (1930); Injury (2348)

Event Date 07/19/2018

Event Type  Injury  

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 reported lot.There have been no other similar events for the sterile lot referenced.It was noted that the device is not available for evaluation.Should additional information become available, it will be provided in a supplemental report upon completion of the investigation.Device not returned / not received.

Event Description

It was reported that patient's hip was revised due to impingement.Surgeon also reported suspicion of infection with evidence of poly wear cited as the cause.Intra-operatively, no visual evidence of poly wear was found.Patient was revised to a spacer including a 6 x 127 hfx stem.The trunnion of the stem was impinging with the cup.Sales rep believes that infection was confirmed to prompt implantation of a first stage antibiotic spacer.

Event Description

It was reported that patient's hip was revised due to impingement.Surgeon also reported suspicion of infection with evidence of poly wear cited as the cause.Intra-operatively, no visual evidence of poly wear was found.Patient was revised to a spacer including a 6 x 127 hfx stem.The trunnion of the stem was impinging with the cup.Sales rep believes that infection was confirmed to prompt implantation of a first stage antibiotic spacer.

Manufacturer Narrative

An event regarding rom (impingement) and infection was reported.The rom (impingement) was confirmed through photographs provided.The infection was not confirmed method & results: device evaluation and results: the reported device was not returned however photographs were provided for review.The photographs shows a recently explanted securfit stem.From the photographs provided there is evidence of deep gouging on the neck of the device.Medical records received and evaluation: no medical records were received for review with a clinical consultant device history review: all 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 reported lot or sterile lot.Conclusion: the exact cause of the event (infection) could not be determined because insufficient information was provided.While the rom (impingement) event was confirmed through photographs provided the root cause could not be determined.Additional information, including operative reports, progress notes, x-rays and return of the device are needed to fully investigate the event.If further information becomes available or the product is returned, this investigation will be re-opened.

• Brand Name: SECUR-FIT MAX 127 HIP STEM #8
• Type of Device: PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/CERAMIC/POLYMER, CEMENTED OR NON-POROU
• Manufacturer (Section D): STRYKER ORTHOPAEDICS-MAHWAH; 325 corporate drive; mahwah NJ 07430
• MDR Report Key: 7789288
• MDR Text Key: 117305002
• Report Number: 0002249697-2018-02559
• Device Sequence Number: 1
• Product Code: LZO
• UDI-Device Identifier: 07613327021110
• UDI-Public: 07613327021110
• Combination Product (y/n): N
• PMA/PMN Number: K051738
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,other
• Type of Report: Initial,Followup
• Report Date: 09/18/2018

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
• Device Operator: Health Professional
• Device Expiration Date: 11/30/2012
• Device Catalogue Number: 6052-0830S
• Device Lot Number: DY3MPD
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 07/19/2018
• Initial Date FDA Received: 08/16/2018
• Supplement Dates Manufacturer Received: 08/21/2018
• Supplement Dates FDA Received: 09/18/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 56 YR
• Patient Weight: 84