MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH RESTORATION GAP RING; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, CEMENTED

Catalog Number 2083-0060

Device Problems Break (1069); Fracture (1260); Material Integrity Problem (2978)

Patient Problems Pain (1994); Injury (2348)

Event Date 10/30/2015

Event Type  Injury  

Manufacturer Narrative

An evaluation of the device cannot be performed as the device was not returned to the manufacturer.Additional information was requested and if it becomes available will be submitted in a supplemental report.

Event Description

Patient came into doctor's office complaining of pain (right), upon viewing x-rays and noticing broken screws and broken gap ring.Scheduled patient for revision surgery following day.Patient denies any falls.

Manufacturer Narrative

An event regarding fracture involving a restoration gap ring was reported.The event was confirmed.Method and results: device evaluation and results: the device was not returned for evaluation; medical records received and evaluation: insufficient medical records were received for review with a clinical consultant; device history review: the device was manufactured and accepted into final stock with no reported discrepancies; complaint history review: there have been no other events for the reported lot.Conclusions: a review of the x-ray by the clinican confirmed the fracture of the acetabular components.However, the exact cause of the event could not be determined as further information such as 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 as no devices and / or insufficient information was received by (b)(4).If devices and / or additional information become available, this investigation will be reopened.

Event Description

Patient came into doctor's office complaining of pain (right), upon viewing x-rays and noticing broken screws and broken gap ring.Scheduled patient for revision surgery following day.Patient denies any falls.

• Brand Name: RESTORATION GAP RING
• Type of Device: PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, CEMENTED
• 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: beverly lima ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 5233965
• MDR Text Key: 31551307
• Report Number: 0002249697-2015-03885
• Device Sequence Number: 1
• Product Code: JDI
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K970957
• 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,Followup
• Report Date: 10/30/2015

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?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 12/31/2006
• Device Catalogue Number: 2083-0060
• Device Lot Number: 3W3039A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/30/2015
• Initial Date FDA Received: 11/18/2015
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 01/28/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/16/2003
• 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): Required Intervention
• Patient Age: 79 YR
• Patient Weight: 120