MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH 6.5MM LOW PROFILE HEX SCREW 25MM; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED

Catalog Number 7030-6525

Device Problems Metal Shedding Debris (1804); Device Operates Differently Than Expected (2913)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 01/23/2018

Event Type  malfunction  

Manufacturer Narrative

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.

Event Description

Primary procedure, right hip.It was reported that the screw passed entirely through the cup.The screw could not be extracted and was left in the patient but a metal shaving was retrieved from the cup.The surgeon placed another screw in the cup to provide fixation.No surgical delay was caused.

Manufacturer Narrative

An event regarding an assembly issue and crack/fracture involving a bone screw was reported.The event was confirmed following a review by a clinical consultant.Conclusions: a review by a clinical consultant concluded: [.] implantation of a hex bone screw intended for supplemental screw fixation under a rather steep angle caused the relatively sharp edge of the flat screw head to cut through the relatively soft titanium of the cup shell perforating same.No adverse consequences are to be expected now or in the future.If additional information and/or device become available, this investigation will be reopened.

Event Description

Primary procedure, right hip.It was reported that the screw passed entirely through the cup.The screw could not be extracted and was left in the patient but a metal shaving was retrieved from the cup.The surgeon placed another screw in the cup to provide fixation.No surgical delay was caused.

• Brand Name: 6.5MM LOW PROFILE HEX SCREW 25MM
• Type of Device: PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED
• Manufacturer (Section D): STRYKER ORTHOPAEDICS-MAHWAH; 325 corporate drive; mahwah NJ 07430
• MDR Report Key: 7282608
• MDR Text Key: 100657558
• Report Number: 0002249697-2018-00488
• Device Sequence Number: 1
• Product Code: LPH
• UDI-Device Identifier: 07613327345001
• UDI-Public: 07613327345001
• Combination Product (y/n): N
• PMA/PMN Number: K161569
• 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: 04/05/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 04/30/2022
• Device Catalogue Number: 7030-6525
• Device Lot Number: AYUA
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 01/23/2018
• Initial Date FDA Received: 02/20/2018
• Supplement Dates Manufacturer Received: 03/12/2018
• Supplement Dates FDA Received: 04/05/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 61 YR