MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH UNKNOWN MDM METAL LINER; PROSTHESIS, HIP, SEMI-CONSTRAINED, UNCEMENTED, METAL/POLYMER, NON-POROUS, CALICU

Model Number	6260-9-328
Medical Device Problem Code	Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	Joint Dislocation (2374)
Date of Event	12/22/2020
Type of Reportable Event	Serious Injury
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 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.Device not returned.
Event or Problem Description
It was reported that the patient's left hip was revised due to dissociation of the femoral head from the poly insert, and dislocation of the poly insert from the metal liner.Patient was revised from a 28mm + 8 lfit femoral head and restoration x3 insert to new devices of the same type and size.Rep will be providing pictures and xrays.
Additional Manufacturer Narrative
Corrected data: update to device details, d1, d2, d4, h4 - the device has changed from a 28mm +8 lfit v40 head to an unknown mdm metal liner.Reported event: an event regarding dislocation involving an unknown mdm liner was reported.The event was confirmed via clinician review.Method & results -product evaluation and results: material analysis, visual, functional and dimensional inspections could not be performed as the device remained implanted -clinician review: a review of the provided medical information by a clinical consultant indicated: no clinical or pmh, no patient demographics, no operative reports, no dated serial x-rays, no examination of explanted components.While the information provided is consistent with the stated event description, insufficient data is presented to create a medical report for this case.-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 patient's left hip was revised due to dissociation of the femoral head from the poly insert, and dislocation of the poly insert from the metal liner.Clinician review of provided medical records indicated that the information provided is consistent with the stated event description.The exact cause of the event could not be determined because insufficient information was provided.Further information such as device lot details, clinical or patient history review (pmh), patient demographics, operative reports, dated serial x-rays, examination of explanted components are needed to complete the investigation for determining root cause.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
It was reported that the patient's left hip was revised due to dissociation of the femoral head from the poly insert, and dislocation of the poly insert from the metal liner.Patient was revised from a 28mm + 8 lfit femoral head and restoration x3 insert to new devices of the same type and size.Rep will be providing pictures and xrays.

• Brand Name: UNKNOWN MDM METAL LINER
• Common Device Name: PROSTHESIS, HIP, SEMI-CONSTRAINED, UNCEMENTED, METAL/POLYMER, NON-POROUS, CALICU
• Manufacturer (Section D): STRYKER ORTHOPAEDICS-MAHWAH; 325 corporate drive; mahwah NJ 07430
• MDR Report Key: 11156402
• Report Number: 0002249697-2021-00103
• Device Sequence Number: 3381662
• Product Code: MEH
• UDI-Device Identifier: 07613327013115
• UDI-Public: 07613327013115
• Combination Product (Y/N): N
• Initial Reporter State: CT
• Initial Reporter Country: US
• PMA/510(K) Number: K173499
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Device Explanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 03/03/2021

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: 09/30/2022
• Device Model Number: 6260-9-328
• Device Catalogue Number: 6260-9-328
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 12/22/2020
• Supplement Date Received by Manufacturer: 02/03/2021
• Initial Report FDA Received Date: 01/12/2021
• Supplement Report FDA Received Date: 03/03/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention