MAUDE Adverse Event Report: SMITH & NEPHEW, INC. REF SPHER HEAD SCREW 30MM; PROSTHESIS, HIP, SEMI-CONSTRAINED, UNCEMENTED, METAL/POLYMER, NON-POROUS, CA-P

Catalog Number 71332530

Device Problems Failure To Adhere Or Bond (1031); Break (1069); Fracture (1260)

Patient Problems Failure of Implant (1924); Pain (1994)

Event Date 03/22/2017

Event Type  Injury  

Event Description

It was reported that a revision surgery occured due to breakage of screw.Patient complained of pain in (b)(6) 2017 but x-rays didn't show anything.Surgeon decided to operate as he was aware that the trochanter had a non-union.Intraoperatively it was discovered that 30mm spherical head screws had broken.Surgeon revised the cup, 5 fixation screws and the liner.

• Brand Name: REF SPHER HEAD SCREW 30MM
• Type of Device: PROSTHESIS, HIP, SEMI-CONSTRAINED, UNCEMENTED, METAL/POLYMER, NON-POROUS, CA-P
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks road; memphis TN 38116
• Manufacturer (Section G): SMITH & NEPHEW, INC.; 1450 brooks road; memphis TN 38116
• Manufacturer Contact: markus poettker ; schachenallee 29; aarau 5001 ; SZ 5001
• MDR Report Key: 6471715
• MDR Text Key: 72094795
• Report Number: 1020279-2017-00245
• Device Sequence Number: 1
• Product Code: MEH
• UDI-Device Identifier: 03596010460479
• UDI-Public: 03596010460479
• Combination Product (y/n): N
• Reporter Country Code: SF
• PMA/PMN Number: K990666
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 08/31/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/07/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 71332530
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/18/2017
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/22/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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
• Treatment: R3 20DEG XLPEACET LNR 36MMX60MM, (B)(4)/14GM19376; R3 MULTIHOLE ACETAB SHELL60MM,(B)(4)/14DM02893; REF SPHER HEAD SCREW 15MM, (B)(4)/13MM11402; REF SPHER HEAD SCREW 20MM, (B)(4)/15CM17075; REF SPHER HEAD SCREW 20MM, (B)(4)/15CM17075; REF THREADED HOLE COVER, (B)(4)/15EM05045; UNKNOWN REF SPHER HEAD SCREW
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 73 YR