MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH REST HA 205MM STRT STM 9X13MM; PROSTHESIS, HIP, SEMI-CONSTRAINED, UNCEMENTED, METAL/POLYMER, NON-POROUS, CALICU

Catalog Number 6013-0913

Device Problems Break (1069); Difficult to Remove (1528); Metal Shedding Debris (1804); Insufficient Information (3190)

Patient Problems Injury (2348); Reaction (2414); No Code Available (3191)

Event Date 01/04/2017

Event Type  Injury  

Manufacturer Narrative

Should additional information become available it will be reported in a supplemental report upon completion of the investigation.

Event Description

The patient was diagnosed with metallosis.This is the second revision surgery for this patient.The first revision surgery was performed in order to replace a ceramic insert that was broken.It was difficult to remove the broken insert but finally the procedure was successful.Acetabular shell was maintained inside the patient and the insert and acetabular head were replaced.

Manufacturer Narrative

Corrected data: device not returned.An event regarding metallosis involving a trident liner and metal head was reported.Conclusion: a review by a clinical consultant concluded, ceramic wear debris still present after a previous revision for ceramic bearing fracture has contributed to third-body wear in the new post-revision articulation with rapidly progressive x3 poly wear and c-taper femoral head metallosis requiring a second revision only 8-months later.The observed metallosis is thus also secondary to the ceramic wear debris of the first revision surgery.Based on this conclusion there is no allegation the product reported in this investigation did not contribute to the event.Failure to remove ceramic debris from a previous revision.No further investigation is required at this time.If additional information becomes available to indicate further evaluation is warranted, this record will be reopened.

Event Description

The patient was diagnosed with metallosis.This is the second revision surgery for this patient.The first revision surgery was performed in order to replace a ceramic insert broken.It was difficult to remove the broken insert but finally the procedure was successful.Acetabular shell was maintained inside the patient and the insert and acetabular head were replaced.

• Brand Name: REST HA 205MM STRT STM 9X13MM
• 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-MAHWAH; 325 corporate drive; mahwah NJ 07430
• Manufacturer Contact: cindy chuhinko ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 6487317
• MDR Text Key: 72630391
• Report Number: 0002249697-2017-01232
• Device Sequence Number: 1
• Product Code: MEH
• Combination Product (y/n): N
• Reporter Country Code: AR
• PMA/PMN Number: K944836
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,other
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 06/09/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/12/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 01/31/2015
• Device Catalogue Number: 6013-0913
• Device Lot Number: MHPLHT
• Was Device Available for Evaluation?: No
• Date Returned to Manufacturer: 04/06/2017
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 05/12/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/30/2010
• 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
• Patient Weight: 74