MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH RESTORATION ADM X3 INS 28/48; PROSTHESIS, HIP, SEMI-CONSTRAINED, UNCEMENTED, METAL/POLYMER, NON-POROUS, CALICU

Model Number 1236-2-848

Device Problems Degraded (1153); Fracture (1260)

Patient Problems Fall (1848); Pain (1994)

Event Date 09/23/2021

Event Type  Injury  

Manufacturer Narrative

Review of the device history records indicate devices were manufactured and accepted into final stock with no relevant reported discrepancies.There have been no other similar events for the lot referenced.A supplemental report will be provided upon completion of the investigation.

Event Description

It was reported that the patient's right hip was revised.After the patient fell, he complained of pain.Intra-operatively, it was discovered that there was a piece broken off of the adm/ mdm poly insert.The insert and femoral head were revised.

Manufacturer Narrative

Reported event: an event regarding crack/fracture and wear 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 liner is damaged on the rim.The damage present on the rim is consistent with delamination and material loss.Burnishing, scratching, and third body indentations are also observed which are common damage modes of uhmwpe.Hackles are observed on the fractured surface are consistent with a fracture in overload.-clinician review: no medical records were received for review with a clinical consultant.-product history review: review of the device history records indicate the 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 liner.Visual inspection of the returned device indicated that the liner is damaged on the rim.The damage present on the rim is consistent with delamination and material loss.Burnishing, scratching, and third body indentations are also observed which are common damage modes of uhmwpe.Hackles are observed on the fractured surface are consistent with a fracture in overload.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.

Event Description

It was reported that the patient's right hip was revised.After the patient fell, he complained of pain.Intra-operatively, it was discovered that there was a piece broken off of the adm/ mdm poly insert.The insert and femoral head were revised.

• Brand Name: RESTORATION ADM X3 INS 28/48
• 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: anna ryan ; raheen business park; limerick NA ; EI NA ; 61498200
• MDR Report Key: 12665802
• MDR Text Key: 277421507
• Report Number: 0002249697-2021-01731
• Device Sequence Number: 1
• Product Code: MEH
• UDI-Device Identifier: 04546540638977
• UDI-Public: 04546540638977
• 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
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 11/18/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/20/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 1236-2-848
• Device Catalogue Number: 1236-2-848
• Device Lot Number: 77831301
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/05/2021
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/26/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/27/2020
• 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: 82 YR
• Patient Sex: Male
• Patient Weight: 92 KG