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

Model Number	626-00-38D
Medical Device Problem Codes	Malposition of Device (2616); Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/10/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
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
The mdm metal liner was found to be locked slantwise postoperative x-ray.The doctor said that he had checked during the surgery to make sure that it was not slanted.The root cause is unknown, but since there is no complications on the patient at the moment, he will wait and see.
Additional Manufacturer Narrative
Reported event: an event regarding seating/locking issues involving an mdm liner was reported.The event was confirmed via clinician review of provided medical records.Method & results: product evaluation and results: material analysis, visual, functional and dimensional inspections could not be performed as the device remains implanted.Clinician review: a review of the provided medical information by a clinical consultant indicated: "this patient underwent a total hip arthroplasty and on a postoperative x-ray it was noticed that the mdm liner was not seated properly.The summary states that "the doctor said that he had checked during the surgery to make sure that it was not slanted." i have done over a thousand mdm implants and have had 3 liners that show incomplete seating/tilt, almost always seen inferiorly.This x-ray does not show slight incomplete seating/tilt/slant.It shows that the liner is not fully inserted into the depth of the acetabular component.The fact that one can see the outline of screw holes means there is a rather significant distance between the metal liner and the acetabular component.I can confirm that the event occurred since i am able to review the x-rays.Regarding root cause, i can only postulate two possibilities.Both are iatrogenic.I find it hard to believe that upon checking circumferentially around the liner for proper contact, that this gap would not be noticed.The other possible scenario is that the liner may have been placed properly or with a slight tilt, but not impacted, resulting in a loose line that could change in position as the patient began to walk on the hip.In my opinion, this is an error in surgical technique and i would assign no causality to the implant itself.In the few cases of incomplete seating in my experience, these were only one to 2 mm of tilt.The liner was impacted solidly in these were left in situ.These patients have been asymptomatic and had no issues with metal ion levels after several years.In this case however i would be concerned about leaving this liner in this position.I believe the patient would be at risk for disassociation and also abnormal forces which could result in ion shedding." product history review: could not be performed as the device lot details were not provided.Complaint history review: could not be performed as the device lot details were not provided.Conclusions: it was reported that the mdm metal liner was found to be locked slantwise postoperative x-ray.A review of the provided medical information by a clinical consultant indicated: "this patient underwent a total hip arthroplasty and on a postoperative x-ray it was noticed that the mdm liner was not seated properly.The summary states that "the doctor said that he had checked during the surgery to make sure that it was not slanted." i have done over a thousand mdm implants and have had 3 liners that show incomplete seating/tilt, almost always seen inferiorly.This x-ray does not show slight incomplete seating/tilt/slant.It shows that the liner is not fully inserted into the depth of the acetabular component.The fact that one can see the outline of screw holes means there is a rather significant distance between the metal liner and the acetabular component.I can confirm that the event occurred since i am able to review the x-rays.Regarding root cause, i can only postulate two possibilities.Both are iatrogenic.I find it hard to believe that upon checking circumferentially around the liner for proper contact, that this gap would not be noticed.The other possible scenario is that the liner may have been placed properly or with a slight tilt, but not impacted, resulting in a loose line that could change in position as the patient began to walk on the hip.In my opinion, this is an error in surgical technique and i would assign no causality to the implant itself.In the few cases of incomplete seating in my experience, these were only one to 2 mm of tilt.The liner was impacted solidly in these were left in situ.These patients have been asymptomatic and had no issues with metal ion levels after several years.In this case however i would be concerned about leaving this liner in this position.I believe the patient would be at risk for disassociation and also abnormal forces which could result in ion shedding." no further investigation for this event is possible at this time.If devices and/or additional information become available to indicate further evaluation is warranted, this record will be reopened.
Event or Problem Description
The mdm metal liner was found to be locked slantwise postoperative x-ray.The doctor said that he had checked during the surgery to make sure that it was not slanted.The root cause is unknown, but since there is no complications on the patient at the moment, he will wait and see.

• 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: arokiya raj ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 14634342
• Report Number: 0002249697-2022-00811
• Device Sequence Number: 3625700
• Product Code: LZO
• UDI-Device Identifier: 04546540666000
• UDI-Public: 04546540666000
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K103233
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 10/20/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 626-00-38D
• Device Catalogue Number: 626-00-38D
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 05/16/2022
• Supplement Date Received by Manufacturer: 10/01/2022
• Initial Report FDA Received Date: 06/08/2022
• Supplement Report FDA Received Date: 10/20/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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: Other
• Patient Sex: Unknown