MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH 32MM -4 V40 TAPER VIT HEAD; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, CEMENTED

Model Number	6260-5-032
Medical Device Problem Codes	Degraded (1153); Insufficient Device Problem Information (3190)
Health Effect - Clinical Codes	Ambulation or Postural Difficulties (2544); Metal Related Pathology (4530); Insufficient Information (4580)
Date of Event	02/28/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
The neck of the stem was broken.Limited activities.
Additional Manufacturer Narrative
It was noted that the device is not available for evaluation.If additional information is received, it will be provided in a supplemental report upon completion of the investigation.Review of the device history records indicate devices were manufactured and accepted into final stock with no reported discrepancies.There have been no other events for the lot referenced.
Additional Manufacturer Narrative
Reported event: an event regarding wear involving a metal head was reported.The event was not confirmed.Method & results: product evaluation and results visual inspection: damage was observed on the head taper.This damage was consistent with the interaction between the head taper and stem trunnion.Slight debris was observed on the articulating surface and taper of the head.Explantation damage observed.Material analysis: not performed as visual inspection provided no indication that the event was a result of a material integrity issue.If further information becomes available additional testing will be performed.-clinician review: a review of the provided medical information by a clinical consultant indicated: "the ap pelvis x-ray shows the presence of bilateral pressfit thas.On the left side there is angulation of the head in relation to the trunnion of the stem.This is consistent with trunnionosis and massive material loss or fracture of the stems femoral neck.The mechanical complication of a femoral component trunnion/neck failure is confirmed.The root cause for this failure cannot be determined from this limited documentation.Should further information become available i would be happy to further this assessment." 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 stem neck fracture.Visual inspection: damage was observed on the head taper.This damage was consistent with the interaction between the head taper and stem trunnion.Slight debris was observed on the articulating surface and taper of the head.Explantation damage observed."the ap pelvis x-ray shows the presence of bilateral pressfit thas.On the left side there is angulation of the head in relation to the trunnion of the stem.This is consistent with trunnionosis and massive material loss or fracture of the stems femoral neck.The mechanical complication of a femoral component trunnion/neck failure is confirmed.The root cause for this failure cannot be determined from this limited documentation.Should further information become available i would be happy to further this assessment." no further investigation for this event is possible at this time.If additional information become available to indicate further evaluation is warranted, this record will be reopened.
Event or Problem Description
The neck of the stem was broken.Limited activities.
Event or Problem Description
The neck of the stem was broken.Limited activities.
Additional Manufacturer Narrative
Reported event: an event regarding wear involving a metal head was reported.The event was confirmed via evaluation of the returned devices and through clinician review of provided medical records.Method & results: product evaluation and results visual inspection: damage was observed on the head taper.This damage was consistent with the interaction between the head taper and stem trunnion.Slight debris was observed on the articulating surface and taper of the head.Explantation damage observed.Material analysis: not performed as visual inspection provided no indication that the event was a result of a material integrity issue.If further information becomes available additional testing will be performed.Clinician review: a review of the provided medical information by a clinical consultant indicated: "the ap pelvis x-ray shows the preence of bilateral pressfit thas.On the left side there is angulation of the head in relation to the trunnion of the stem.This is consistent with trunnionosis and massive material loss or fracture of the stems femoral neck.The mechanical complication of a femoral component trunnion/neck failure is confirmed.The root cause for this failure cannot be determined from this limited documentation.Should further information become available i would be happy to further this assessment." 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 stem neck fracture.Visual inspection: damage was observed on the head taper.This damage was consistent with the interaction between the head taper and stem trunnion.Slight debris was observed on the articulating surface and taper of the head.Explantation damage observed."the ap pelvis x-ray shows the preence of bilateral pressfit thas.On the left side there is angulation of the head in relation to the trunnion of the stem.This is consistent with trunnionosis and massive material loss or fracture of the stems femoral neck.The mechanical complication of a femoral component trunnion/neck failure is confirmed.The root cause for this failure cannot be determined from this limited documentation.Should further information become available i would be happy to further this assessment." no further investigation for this event is possible at this time.If additional information become available to indicate further evaluation is warranted, this record will be reopened.

• Brand Name: 32MM -4 V40 TAPER VIT HEAD
• Common Device Name: PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, CEMENTED
• 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: 16668847
• Report Number: 0002249697-2023-00353
• Device Sequence Number: 20543953
• Product Code: JDI
• UDI-Device Identifier: 07613327012842
• UDI-Public: 07613327012842
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K121308
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2011
• Device Explanted Year: 2023
• Reporter Type: Manufacturer
• Report Source: Other,Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 03/20/2024

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: 03/31/2016
• Device Model Number: 6260-5-032
• Device Catalogue Number: 6260-5-032
• Device Lot Number: 36458502
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/08/2023
• Supplement Date Received by Manufacturer: 07/12/2023; 02/21/2024
• Initial Report FDA Received Date: 04/03/2023
• Supplement Report FDA Received Date: 07/31/2023; 03/20/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 03/24/2011
• 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: 71 YR
• Patient Sex: Female