MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH RESTORATION ADM X3 INS 28/56 PROSTHESIS, HIP, SEMI-CONSTRAINED, UNCEMENTED, METAL/POLYMER, NON-POROUS, CALICU

Catalog Number 1236-2-856

Device Problem Device Dislodged or Dislocated (2923)

Patient Problems Fall (1848); Muscle Weakness (1967); Injury (2348); Joint Dislocation (2374)

Event Date 03/20/2017

Event Type  Injury  

Manufacturer Narrative

An event regarding dislocation involving a adm liner was reported. The event was confirmed through the medical review. Method & results: device evaluation and results: not performed as the reported device was not returned for evaluation. Medical records received and evaluation: a medical review was performed and concluded: the irreducible nature of the dislocation is a procedure-related design characteristic while there are no device-related factors evident from the available material. As such is this case not device-related. Procedure-related factors: cup malposition in low inclination as secondary factor. Patient-related factors patient trauma with a fall as principal failure mode. Cardiac disease and alcohol abuse may have increased the propensity to falling. Device-related factors: none. Diagnosis: patient trauma has caused a dislocation of the adm liner possibly related to additional cardiac disease where the irreducible nature of the dislocation is a procedure-related design characteristic requiring open reduction in case of dislocation. Hip abductor weakness is a secondary effect of multiple revision surgeries. Device history review: review indicated all devices were manufactured and accepted into final stock with no reported discrepancies. Complaint history review: review indicated there have been no other similar events for the reported lot. Conclusions: a medical review was provided and concluded that "patient trauma has caused a dislocation of the adm liner possibly related to additional cardiac disease where the irreducible nature of the dislocation is a procedure-related design characteristic requiring open reduction in case of dislocation. Hip abductor weakness is a secondary effect of multiple revision surgeries. " there was no indication of a device related issue on review of the clinical review. No further investigation is required at this time. If further relevant information becomes available or the product is returned, this investigation will be re-opened.

Event Description

Patient had a previous rejuvenate left hip that was revised to a securfit and adm shell and liner on (b)(6) 2012. Patient recently dislocated hip and the head and liner were revised due to disassociation of 28mm ball from adm poly liner insert. The appropriate size 56 head and head ball were reimplanted. Patient's hip was reduced and surgeon commented the abductors were compromised.

Manufacturer Narrative

An evaluation of the device cannot be performed as the device was retained by the patient and was not returned to the manufacturer. Additional information has been requested. Should additional information become available it will be reported in a supplemental report upon completion of the investigation.

Event Description

Patient had a previous rejuvenate left hip that was revised to a securfit and adm shell and liner on (b)(6) 2012. Patient recently dislocated hip and the head and liner were revised due to disassociation of 28 mm ball from adm poly liner insert. The appropriate size 56 head and head ball were reimplanted. Patient's hip was reduced and surgeon commented the abductors were compromised.

• Brand Name: RESTORATION ADM X3 INS 28/56
• 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: cindy chuhinko ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 6490553
• MDR Text Key: 197093305
• Report Number: 0002249697-2017-01254
• 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

• Type of Report: Initial,Followup
• Report Date: 07/19/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/13/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No

Device Operator

• Device Expiration Date: 05/18/2016
• Device Catalogue Number: 1236-2-856
• Device Lot Number: 36963601
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes

Was the Report Sent to FDA?

• Event Location: No Information
• Date Manufacturer Received: 06/21/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/18/2011
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial

Patient Treatment Data

Date Received: 04/13/2017 Patient Sequence Number: 1