MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH RESTORATION ADM X3 INS 28/58; PROSTHESIS, HIP, SEMI-CONSTRAINED, UNCEMENTED, METAL/POLYMER, NON-POROUS, CALICU

Model Number	1236-2-858
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Unspecified Infection (1930)
Date of Event	04/09/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The following devices were also listed in this report: 28mm +4 lfit v40 head; 6260-9-228 ;81630908.Md vit slv and 2.0mm homog cbl; 6704-0-510 ; 77250711.Md vit slv and 2.0mm homog cbl; 6704-0-510; 74137305.6.5 cancellous bone screw 20mm; 2030-6520-1; lot unknown.6.5 cancellous bone screw 20mm; 2030-6520-1; lot unknown.Modular dual mobility insert; 626-00-52h; lot unknown.It cannot be determined which, if any of these devices may have caused or contributed to the patient's experience.Reported event: an event regarding infection involving a adm liner reported.The event was not confirmed.Method & results: product evaluation and results: not performed as product was not returned clinician review: no medical records were received for review with a clinical consultant.Product history review: indicated the devices accepted into final stock from the reported lot were free from discrepancies.   complaint history review: no other similar events were reported for the lot or sterile lot.  conclusions: all stryker products sold as sterile are validated to a minimum sterility assurance level sal of 10^-6 in accordance to applicable iso standards.The exact cause of the event could not be determined because insufficient information was provided.Further information such as return of the device, pathology reports, pre- and post-operative x-rays and the primary operative report as well as patient history and follow-up notes 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 right hip was revised due to infection.All reported devices were revised.Patient had previously had a poly swap the week before.Rep confirmed that no further information will be released by the hospital or surgeon.

• Brand Name: RESTORATION ADM X3 INS 28/58
• 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: 11770794
• Report Number: 0002249697-2021-00782
• Device Sequence Number: 4168118
• Product Code: MEH
• UDI-Device Identifier: 04546540639028
• UDI-Public: 04546540639028
• Combination Product (Y/N): N
• Initial Reporter State: MI
• Initial Reporter Country: US
• PMA/510(K) Number: K093644
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Device Explanted Year: 2021
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 05/04/2021

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: 08/31/2024
• Device Model Number: 1236-2-858
• Device Catalogue Number: 1236-2-858
• Device Lot Number: 423449
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/09/2021
• Initial Report FDA Received Date: 05/04/2021
• 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
• Patient Age: 58 YR
• Patient Weight: 143