MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH RESTORATION ADM X3 INS 28/50; PROSTHESIS, HIP, SEMI-CONSTRAINED, UNCEMENTED, METAL/POLYMER, NON-POROUS, CALICU

Catalog Number 1236-2-850

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

Patient Problems Pain (1994); Joint Dislocation (2374)

Event Date 03/17/2016

Event Type  Injury  

Manufacturer Narrative

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

Event Description

The patient originally underwent a tha using an adept and a super secur fit and the patient underwent revision surgery on (b)(6) 2015 due to pain of inguinal region.The adept cup and super secur fit were left in the patient and implanted adm/adm 50mm insert and 28mm metal head +4mm (cat.: 6260-5-228, lot.45132001).And dislocation was occurred on (b)(6) 2016 and reduction was conducted by the surgeon.The surgeon observed that the patient has a internal dislocation with ct on (b)(6).

Manufacturer Narrative

An event regarding dislocation involving an adm liner was reported.The event was confirmed.Method & results: device evaluation and results: scratching and indentation marks were noted on the surface of the liner.Medical records received and evaluation: a medical review was performed and concluded: "no evidence is present to suggest that device-related matters have played a role while the clinical context and radiological information provide a plausible failure scenario as based upon cup malposition that was persistent leading at first to a revision because of groin pain in 2015 due to iliopsoas tendinitis and because the cup shell was retained in malposition with only a liner exchange, a second revision in 2016 became required because of dislocation.This pi case is not device-related." "cup malposition in absent anteversion has caused a dislocation which because of presence of an adm liner was of the intra-prosthetic type and thus required open revision surgery." device history review: all devices in the reported lot were manufactured and accepted into final stock with no reported discrepancies.Complaint history review: there have been no other similar events for the reported lot.Conclusions: a medical review was performed and concluded that the root cause of the dislocation was related to cup malposition (competitor device).Further to this there was no evidence of device related factors.No further investigation is required at this time.

Event Description

The patient originally underwent a tha using an adept and a super secur fit and the patient underwent revision surgery on (b)(6) 2015 due to pain of inguinal region.The adept cup and super secur fit were left in the patient and implanted adm/adm 50mm insert and 28mm metal head +4mm (cat.: 6260-5-228, lot.45132001).And dislocation was occured on (b)(6) 2016 and reduction was conducted by the surgeon.The surgeon observed that the patient has a internal dislocation with ct on (b)(6).

• Brand Name: RESTORATION ADM X3 INS 28/50
• 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: keyla colon ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 5575047
• MDR Text Key: 42606103
• Report Number: 0002249697-2016-01206
• Device Sequence Number: 1
• Product Code: MEH
• Combination Product (y/n): N
• PMA/PMN Number: K093644
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 03/18/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/13/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 05/31/2018
• Device Catalogue Number: 1236-2-850
• Device Lot Number: 43924801
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/06/2016
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/18/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/13/2013
• 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: 79 YR