MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH RESTORATION ADM X3 INS 28/64; PROSTHESIS, HIP, SEMI-CONSTRAINED, UNCEMENTED, METAL / POLYMER, NON-POROUS, CALC

Model Number	1236-2-864
Health Effect - Clinical Code	Joint Dislocation (2374)
Date of Event	01/23/2021
Type of Reportable Event	Serious Injury
Additional 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.It was noted that the device is not available for evaluation.Should additional information become available, it will be provided in a supplemental report upon completion of the investigation.
Event or Problem Description
It was reported that the patient's left hip was revised.Prior to revision, the patient presented to the e.R.For an unsuccessful closed reduction and the decision was made to revise the hip.Intra-operatively, the adm/ mdm poly was observed to be dislocated from the adm shell, and dissociated from the femoral head.As the surgeon wanted to go with a smaller insert/ head option, the decision was made to revise the shell, head and liner.
Event or Problem Description
It was reported that the patient's left hip was revised.Prior to revision, the patient presented to the e.R.For an unsuccessful closed reduction and the decision was made to revise the hip.Intra-operatively, the adm/ mdm poly was observed to be dislocated from the adm shell, and dissociated from the femoral head.As the surgeon wanted to go with a smaller insert/ head option, the decision was made to revise the shell, head and liner.
Additional Manufacturer Narrative
Reported event: an event regarding dislocation and disassociation involving an adm liner was reported.The event was not confirmed.Method & results: product evaluation and results: the device was retuned for evaluation.There is nothing remarkable noticed on the adm liner.Clinician review: no medical records were received for review with a clinical consultant.Product history review: review of the device history records indicate devices were manufactured and accepted into final stock on 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 adm/ mdm poly liner was observed to be dislocated from the adm shell, and dissociated from the femoral head.The exact cause of the event could not be determined because insufficient information was provided.Further information such as pathology reports, pre- and post-operative x-rays and the primary operative report as well as patient history and follow-up notes are needed to complete the investigation for determining root cause.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 or Problem Description
It was reported that the patient's left hip was revised.Prior to revision, the patient presented to the e.R.For an unsuccessful closed reduction and the decision was made to revise the hip.Intra-operatively, the adm/ mdm poly was observed to be dislocated from the adm shell, and dissociated from the femoral head.As the surgeon wanted to go with a smaller insert/ head option, the decision was made to revise the shell, head and liner.
Additional Manufacturer Narrative
Reported event: an event regarding dislocation and disassociation involving an adm liner was reported.The event was confirmed via clinician review.Method & results product evaluation and results: the device was retuned for evaluation.There is nothing remarkable noticed on the amd liner.Clinician review: a review of the provided medical records by a clinical consultant indicates: this inquiry reports the failure of a dual mobility total hip arthroplasty due to two incidences of intra-prosthetic disassociation.After the second incident of disassociation a revision of the cup was carried out.I can confirm that these events took place since i was able to review hospital and office records, operation reports and photos of x-rays that reveal the pathology.Regarding the possible root cause of these events, i cannot determine it with certainty.Causes of intra-prosthetic disassociation are multifactorial including surgical technique, implant factors and patient factors.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 adm/ mdm poly was observed to be dislocated from the adm shell, and dissociated from the femoral head.The exact cause of the event could not be determined.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 28/64
• Common Device Name: PROSTHESIS, HIP, SEMI-CONSTRAINED, UNCEMENTED, METAL / POLYMER, NON-POROUS, CALC
• 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: marisol santiago ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 11340303
• Report Number: 0002249697-2021-00291
• Device Sequence Number: 823374
• Product Code: MEH
• UDI-Device Identifier: 04546540639059
• UDI-Public: 04546540639059
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K093644
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Device Explanted Year: 2021
• Reporter Type: Manufacturer
• Report Source: Other,Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 02/11/2022

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
• Operator of Device: Health Professional
• Device Expiration Date: 03/31/2021
• Device Model Number: 1236-2-864
• Device Catalogue Number: 1236-2-864
• Device Lot Number: 306625
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/12/2021
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 01/23/2021
• Supplement Date Received by Manufacturer: 04/27/2021; 01/19/2022
• Initial Report FDA Received Date: 02/17/2021
• Supplement Report FDA Received Date: 05/05/2021; 02/11/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/21/2016
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Age: 76 YR
• Patient Sex: Male
• Patient Weight: 93 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White