MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH RESTORATION ADM X3 INS 28/56; IMPLANT

Catalog Number 1236-2-856

Device Problem Device Dislodged or Dislocated (2923)

Patient Problems Fall (1848); Joint Dislocation (2374)

Event Date 11/20/2014

Event Type  Injury  

Event Description

Patient fell and dislocated head from adm liner on left hip.Liner revised.Patient has adm cup and novation stem.

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, the evaluation summary will be submitted in a supplemental report.Device not returned to manufacturer.

Manufacturer Narrative

The patient is (b)(6) in height.An event regarding off label use involving an adm liner was reported.Conclusion: the surgical protocol outlines that the adm insert under the scope of this investigation is only compatible only with 28mm stryker heads.Based on the provided information it has been determined that this event is associated with an off-label application.

Event Description

Patient fell and dislocated head from adm liner on left hip.Liner revised.Patient has adm cup and novation stem.

Manufacturer Narrative

An event regarding dislocation involving an adm liner was reported.The event was confirmed.Method & results: the reported device was not returned for evaluation.A medical review was performed and concluded: dislocation of the left total hip arthroplasty after a fall may have also been related to the vertical position of the acetabular component and the posterior repair having ¿ripped out¿.Revision with a longer modular neck should increase stability.There is no evidence that factors of faulty component design, manufacturing or materials were responsible for this clinical situation.All devices in the reported lot were manufactured and accepted into final stock with no reported discrepancies.There have been no other similar events for the reported lot.Conclusions: a review of the medical records by a clinical consultant concluded that dislocation of the left total hip arthroplasty after a fall may have also been related to the vertical position of the acetabular component and the posterior repair having ¿ripped out¿.There is no evidence that factors of faulty component design, manufacturing or materials were responsible for this clinical situation.No further investigation is required.If further information becomes available or the product is returned, this investigation will be re-opened.

Event Description

Patient fell and dislocated head from adm liner on left hip.Liner revised.Patient has adm cup and novation stem.

• Brand Name: RESTORATION ADM X3 INS 28/56
• Type of Device: IMPLANT
• 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 navedo ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 4343384
• MDR Text Key: 5178432
• Report Number: 0002249697-2014-04763
• 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: Other,Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 11/20/2014

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?: No
• Device Operator: Health Professional
• Device Expiration Date: 10/31/2011
• Device Catalogue Number: 1236-2-856
• Device Lot Number: 38150801
• Other Device ID Number: STERILE LOT 1109W282
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 05/13/2015
• Initial Date FDA Received: 12/18/2014
• Supplement Dates Manufacturer Received: Not provided; Not provided
• Supplement Dates FDA Received: 02/08/2015; 06/25/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/03/2011
• 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: 75 YR
• Patient Weight: 110