MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH RESTORATION ADM X3 INS 28/52; PROSTHESIS, HIP, SEMI-CONSTRAINED, UNCEMENTED, METAL/POLYMER, NON-POROUS, CALICU

Model Number 1236-2-852

Device Problem Fracture (1260)

Patient Problem Insufficient Information (4580)

Event Date 05/17/2021

Event Type  Injury  

Manufacturer Narrative

Should additional information become available it will be reported in a supplemental report upon completion of the investigation.H3 other text : not returned to the manufacturer.

Event Description

It was reported that the patient's hip was revised due to the adm/ mdm poly having broken in half.Rep confirmed that the patient's hip construct was: competitor shell, adm/ mdm poly insert (no mdm liner), competitor femoral head, competitor stem.

Event Description

It was reported that the patient's hip was revised due to the adm/ mdm poly having broken in half.Rep confirmed that the patient's hip construct was: competitor shell, adm/ mdm poly insert (no mdm liner), competitor femoral head, competitor stem.

Manufacturer Narrative

An event regarding crack/fracture involving a adm liner was reported.The event was confirmed via evaluation of the returned device.Method & results: product evaluation and results: visual inspection: visual inspection of the returned device indicated that the device has fractured into 2 pieces.Material analysis: a material analysis was performed and concluded the following: "the uhmwpe poly insert device fractured from overloading.The hackles seen are indications of this fracture mode when seen in uhmwpe.No material non-conformances, nor manufacturing defects were found on any surfaces inspected during the investigation." clinician review: a review of the provided medical information by a clinical consultant indicated: "the event description states: ".Hip was revised due to the adm/mdm poly having broken in half.Competitor shell, adm/mdm poly insert (no mdm liner), competitor femoral head, competitor stem." undated x-ray : ap left hip - uncemented tha, distal stem not visualized, reduced, head concentric but not deeply in acetabular component.1/13/17 x-rays: ap and lat left hip - same tha, head eccentric and deeper in acetabular component, distal stem not visualized.5/17/21 "operative report - left revision tha.Fracture of adm shell.The adm shell was fractured in 2 large pieces.No visible damage to acetabular shell.Adm 52 cup.28/0 biolox head." uncomplicated surgery briefly described.No clinical or pmh, no patient demographics, no dated serial x-rays, no list of implanted components, no examination of explanted components.While the revision operative report of 5/17/21 appears to confirm the event description, insufficient data is presented to create a medical report for this case." -product history review: review of the device history records indicate devices were manufactured and accepted into final stock with no relevant reported discrepancies.-complaint history review: there have been no other similar events for the lot referenced.Conclusions: it was reported that the patient was revised due to fracture of the adm poly liner.Visual inspection of the returned device indicated that the device has fractured into 2 pieces.A material analysis was performed and concluded the following: "the uhmwpe poly insert device fractured from overloading.The hackles seen are indications of this fracture mode when seen in uhmwpe.No material non-conformances, nor manufacturing defects were found on any surfaces inspected during the investigation." it was further reported that the adm poly liner was used with a competitor shell and competitor femoral head.A review of the adm x3 mobile bearing hip system surgical protocol indicated the following: "do not substitute another manufacturer¿s device for any component of the adm acetabular system." it is possible that the usage of the device in this off-label manner contributed to the device failure.No further investigation for this event is possible at this time.If additional information becomes available to indicate further evaluation is warranted, this record will be reopened.

• Brand Name: RESTORATION ADM X3 INS 28/52
• 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 ; EI NA
• Manufacturer Contact: brad curtis ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 11972847
• MDR Text Key: 255761799
• Report Number: 0002249697-2021-01002
• Device Sequence Number: 1
• Product Code: MEH
• UDI-Device Identifier: 04546540638991
• UDI-Public: 04546540638991
• 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
• Report Date: 11/10/2022

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: 02/05/2021
• Device Model Number: 1236-2-852
• Device Catalogue Number: 1236-2-852
• Device Lot Number: 54677601
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 05/17/2021
• Initial Date FDA Received: 06/10/2021
• Supplement Dates Manufacturer Received: 10/18/2022
• Supplement Dates FDA Received: 11/10/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/06/2016
• 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: 59 YR
• Patient Sex: Female