MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH MODULAR DUAL MOBILITY INSERT; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/CERAMIC/POLYMER, CEMENTED OR NON-POROUS

Model Number	626-00-52H
Medical Device Problem Codes	Unstable (1667); Device Dislodged or Dislocated (2923)
Health Effect - Clinical Codes	Ambulation or Postural Difficulties (2544); Joint Laxity (4526); Unequal Limb Length (4534)
Date of Event	04/13/2022
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
This report is for the (b)(6) 2022 revision.In providing information for a revision of the patient's left hip on (b)(6) 2022 the, rep confirmed that on (b)(6) 2022 the hip had been revised as well.An mdm metal liner, adm/ mdm poly insert, femoral head, and restoration modular proximal body were revised to another proximal body and head, and a constrained insert.Update reason for revision: "leg length inequality and instability with history of dislocation.Mdm head dislocation out of mdm liner.".
Event or Problem Description
This report is for the (b)(6) 2022 revision.In providing information for a revision of the patient's left hip on (b)(6) 2022 the, rep confirmed that on (b)(6) 2022 the hip had been revised as well.An mdm metal liner, adm/ mdm poly insert, femoral head, and restoration modular proximal body were revised to another proximal body and head, and a constrained insert.Update reason for revision: "leg length inequality and instability with history of dislocation.Mdm head dislocation out of mdm liner.".
Additional Manufacturer Narrative
Reported event: an event regarding instability involving a mdm liner was reported.The event was not confirmed.Method & results: -device evaluation and results: material analysis, visual, functional and dimensional inspections could not be performed as the device was not returned.-clinician review: a review of medical records with a clinical consultant noted : ""this patient had multiple procedures all related to instability.Initially a primary trident liner was utilized, it was then revised to and mdm.The patient then approximately two years later required a revision where the mdm liner was replaced with a constrained insert.That constrained insert dislocated requiring another procedure.Causes of dislocation of a primary total hip are multifactorial but in most cases is surgical technique related possibly due to malposition of implants and failure to restore soft tissue tension.Later dislocation can be due to factors such as trauma and stretching out of the soft tissue envelope around the hip.Causes of dislocation of a constrained liner immediately after surgery may also be surgical technique related in that the liner may not have been properly seated.Another cause could be trauma but none was reported in this case.Regarding the event, i can confirm that a dislocation of the constrained liner occurred since i was able to see an xray showing the dislocation.I have no way to confirm any other event since i have no supporting documentation or x-rays.Regarding the root cause of the event, i believe it is likely that surgical technique played a significant role and for the late dislocation, most likely the soft tissues stretched allowing increased laxity in the joint." -device 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 event s for the lot referenced.Conclusion: it was reported that patient was revised due to "leg length inequality and instability with history of dislocation.Mdm head dislocation out of mdm liner".A review of medical records with a clinical consultant noted : ""this patient had multiple procedures all related to instability.Initially a primary trident liner was utilized, it was then revised to and mdm.The patient then approximately two years later required a revision where the mdm liner was replaced with a constrained insert.That constrained insert dislocated requiring another procedure.Causes of dislocation of a primary total hip are multifactorial but in most cases is surgical technique related possibly due to malposition of implants and failure to restore soft tissue tension.Later dislocation can be due to factors such as trauma and stretching out of the soft tissue envelope around the hip.Causes of dislocation of a constrained liner immediately after surgery may also be surgical technique related in that the liner may not have been properly seated.Another cause could be trauma but none was reported in this case.Regarding the event, i can confirm that a dislocation of the constrained liner occurred since i was able to see an xray showing the dislocation.I have no way to confirm any other event since i have no supporting documentation or x-rays.Regarding the root cause of the event, i believe it is likely that surgical technique played a significant role and for the late dislocation, most likely the soft tissues stretched allowing increased laxity in the joint.".

• Brand Name: MODULAR DUAL MOBILITY INSERT
• Common Device Name: PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/CERAMIC/POLYMER, CEMENTED OR NON-POROUS
• 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: 14342959
• Report Number: 0002249697-2022-00669
• Device Sequence Number: 15007121
• Product Code: LZO
• UDI-Device Identifier: 04546540666048
• UDI-Public: 04546540666048
• Combination Product (Y/N): N
• Initial Reporter State: NV
• Initial Reporter Country: US
• PMA/510(K) Number: K103233
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Device Explanted Year: 2022
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 08/01/2022

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: 02/28/2025
• Device Model Number: 626-00-52H
• Device Catalogue Number: 626-00-52H
• Device Lot Number: 77588001
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/13/2022
• Supplement Date Received by Manufacturer: 07/08/2022
• Initial Report FDA Received Date: 05/09/2022
• Supplement Report FDA Received Date: 08/01/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 02/28/2020
• 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: 68 YR
• Patient Sex: Female
• Patient Ethnicity: Non Hispanic
• Patient Race: White