MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH RESTORATION ADM X3 INS; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/CERAMIC/POLYMER, CEMENTED OR NON-POROUS

Model Number	1236-2-244
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Codes	Pain (1994); Injury (2348)
Date of Event	05/20/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Review of the device history records indicate that devices were manufactured and accepted into final stock with no reported discrepancies.There have been no other events for the lot referenced.If additional information is received, it will be provided in a supplemental report upon completion of the investigation.The following devices were also listed in this report: modular dual mobility insert; 626-00-38d ; 70579102, 22.2mm + 3 lfit v40 head; 6260-9-222 ; 72332005, size 5 accolade ii 127 deg;6721-0535;74204404.It cannot be determined which, if any of these devices may have caused or contributed to the patient's experience.Device not returned.
Event or Problem Description
It was reported that the patient's left hip was revised due to pain.An accolade ii stem, 22.2 +3 lfit head, mdm liner and poly insert were revised to competitor femoral devices and 36d 0° insert.Rep provided primary and revision usage sheets and confirmed that no further information will be released.
Additional Manufacturer Narrative
Corrected the manufacturing and expiration date.Reported event: an event regarding revision due to pain involving a adm liner was reported.The event was not confirmed.Method & results: device evaluation and results: visual, dimensional, functional and material analysis could not be performed as the device was not returned.Clinician review: no medical records were received for review with a clinical consultant.Device history review: all 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 reported lot.Conclusion: it was reported that the patient's left hip was revised due to pain.The event could not be confirmed, nor the root cause determined because the devices were not returned for evaluation and insufficient medical information was provided.Further information such as medical documentation and returned devices are needed.If the devices and/or additional information are received, this investigation will be reopened and re-evaluated.Product surveillance will continue to monitor for trends.H3 other text : device not returned.
Event or Problem Description
It was reported that the patient's left hip was revised due to pain.An accolade ii stem, 22.2 +3 lfit head, mdm liner and poly insert were revised to competitor femoral devices and 36d 0° insert.Rep provided primary and revision usage sheets and confirmed that no further information will be released.

• Brand Name: RESTORATION ADM X3 INS
• 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
• MDR Report Key: 10137193
• Report Number: 0002249697-2020-01118
• Device Sequence Number: 1762182
• Product Code: LZO
• UDI-Device Identifier: 04546540665898
• UDI-Public: 04546540665898
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K103233
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Device Explanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 08/19/2020

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: 08/31/2023
• Device Model Number: 1236-2-244
• Device Catalogue Number: 1236-2-244
• Device Lot Number: 409041
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 05/20/2020
• Supplement Date Received by Manufacturer: 07/23/2020
• Initial Report FDA Received Date: 06/10/2020
• Supplement Report FDA Received Date: 08/19/2020
• 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
• Patient Age: 60 YR