MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH RESTORATION ADM X3 INS 28/58; PROSTHESIS, HIP, SEMI-CONSTRAINED, UNCEMENTED, METAL/POLYMER, NON-POROUS, CALICU

Catalog Number 1236-2-858

Device Problems Device Dislodged or Dislocated (2923); Scratched Material (3020)

Patient Problems Pain (1994); Discomfort (2330); Injury (2348)

Event Date 07/25/2017

Event Type  Injury  

Manufacturer Narrative

A supplemental report will be submitted upon completion of the investigation.

Event Description

It was reported that a patient hip dislocated and complained of extreme hip pain and discomfort.Initial hip revision surgery performed on (b)(6) 2017.68mm tritanium shell, 52mm mdm liner, 52h x3 insert, 30 and 35mm gap screw and a 28mm +4 metal head were implanted during (b)(6) 2017 procedure.Patient presented again with dislocated hip on (b)(6)2017.Once patient incised and hip joint visible, the mdm construct was found to be not intact, metal head still attached to trunion of stem but 52h effective head had disassociated from metal head and was floating freely in hip joint.New 52h x3 insert and 28mm +6 metal head implanted, joint reduced and stability satisfactory.

Manufacturer Narrative

An event regarding dislocation involving an adm liner and was reported.The event was not confirmed.Visual inspection: the returned adm liner has scratches on the rim and outer spherical surface.The device was found to be dimensionally within specification as per igs-0029578 version 5 with the exception of sequence 4 and 9 (b diameter).The report on dimensional inspection noted: "a review of the original ohr confirmed that the b diameter of the returned device was in specification at the time of manufacture.During the original in¿process inspection, as per igs requirements, the b dimension is checked on i00% of parts during the in¿process inspection.The b diameter feature is also checked on a coordinate measuring machine (cmm) on the first and last part of the original batch of 18 parts.It is likely that the assembly and disassociation of the liner and femoral head resulted in the b diameter going out of specification no medical records were received for review with a clinical consultant.Review indicated all devices were manufactured and accepted into final stock with no relevant reported discrepancies.Review indicated there have been no other similar events for the reported lot.The event and exact cause of the event could not be determined due to a lack of available information.Further information such as pre- and post-operative x-rays and the primary 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.If additional information becomes available, this investigation will be reopened.

Event Description

It was reported that a patient hip dislocated and complained of extreme hip pain and discomfort.Initial hip revision surgery performed on (b)(6) 2017.68mm tritanium shell,52mm mdm liner,52h x3 insert, 30 and 35mm gap screw and a 28mm +4 metal head were implanted during (b)(6) 2017 procedure.Patient presented again with dislocated hip on (b)(6) 2017.Once patient incised and hip joint visible, the mdm construct was found to be not intact, metal head still attached to trunion of stem but 52h effective head had disassociated from metal head and was floating freely in hip joint.New 52h x3 insert and 28mm +6 metal head implanted, joint reduced and stability satisfactory.

• Brand Name: RESTORATION ADM X3 INS 28/58
• Type of Device: PROSTHESIS, HIP, SEMI-CONSTRAINED, UNCEMENTED, METAL/POLYMER, NON-POROUS, CALICU
• Manufacturer (Section D): STRYKER ORTHOPAEDICS-MAHWAH; 325 corporate drive; mahwah NJ 07430
• Manufacturer (Section G): STRYKER ORTHOPAEDICS-CORK; ida industrial estate; carrigtwohill NA
• Manufacturer Contact: brian lauro ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 6805862
• MDR Text Key: 83092130
• Report Number: 0002249697-2017-02549
• Device Sequence Number: 1
• Product Code: MEH
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K093644
• 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: 01/10/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/18/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 02/16/2020
• Device Catalogue Number: 1236-2-858
• Device Lot Number: 50960501
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/23/2017
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/14/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/16/2015
• 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: 71 YR