MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH RESTORATION ADM X3 INS 28/48; PROSTHESIS, HIP, SEMI-CONSTRAINED, UNCEMENTED, METAL/POLYMER, NON-POROUS, CALICU

Model Number	1236-2-848
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Pain (1994)
Date of Event	03/14/2022
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.The following devices were also listed in this report: modular dual mobility insert; cat#626-00-42e ; lot#73068904.Primary secur-fit plus max #8/14; cat#6054-0814s ; lot#ha6axa.Delta c-taper head 28mm +5; cat#18-2805 ; lot#72455401.Tridentii tritanium solid 52e; cat#700-04-52e; lot#71575501a.It cannot be determined which, if any of these devices may have caused or contributed to the patient's experience.
Event or Problem Description
Pt experiencing pain in right hip.Revision total hip.
Event or Problem Description
Pt experiencing pain in right hip.Revision total hip.
Additional Manufacturer Narrative
Reported event: an event regarding pain involving a adm liner was reported.The event was not confirmed.Method & results: device evaluation and results: material analysis, functional and dimensional inspections could not be performed as the device was not returned.Visual inspection - the reported device was not returned however photographs were provided for review.The photographs show a recently explanted device with blood on its surfaces.Nothing else noted.Clinical review: a review of the provided medical records by a clinical consultant stated the following comment: i can confirm that an implant was removed since i was able to see photographs of the explanted devices.Regarding the possible root cause of this event, i cannot determine it with certainty.While a bone scan report questions possible loosening, i have no office notes or operation note or radiographs to corroborate the reason for removal.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: review indicated there have been no other similar events for the reported lot.Conclusion: an event regarding pain involving a adm liner was reported.The event was not confirmed.The exact cause of the event could not be determined because insufficient information was provided.Further information such as office notes, operation note, radiographs are needed.If additional information are received, this investigation will be reopened and re-evaluated.

• Brand Name: RESTORATION ADM X3 INS 28/48
• 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
• 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: 14029822
• Report Number: 0002249697-2022-00480
• Device Sequence Number: 4610010
• Product Code: MEH
• UDI-Device Identifier: 04546540638977
• UDI-Public: 04546540638977
• Combination Product (Y/N): N
• Initial Reporter State: WA
• Initial Reporter Country: US
• PMA/510(K) Number: K093644
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Device Explanted Year: 2022
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 07/04/2022

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: 07/31/2024
• Device Model Number: 1236-2-848
• Device Catalogue Number: 1236-2-848
• Device Lot Number: 73528901
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/14/2022
• Supplement Date Received by Manufacturer: 06/14/2022
• Initial Report FDA Received Date: 04/06/2022
• Supplement Report FDA Received Date: 07/04/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 07/16/2019
• 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: 56 YR
• Patient Sex: Female
• Patient Weight: 67 KG