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	Unspecified Infection (1930)
Date of Event	08/13/2021
Type of Reportable Event	Serious Injury
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.The following devices were also listed in this report: 709-04-52e tridentii tritanium multi 52e 75393701a; 626-00-42e modular dual mobility insert 76268901; 6570-0-228 delta v-40 ceramic head 28/+4 85387301; 64951001 proximal fem comp std ly97b; 64853113 mrs fem stem w/o body 13x127mm 239029b; 64956040 gmrs extension piece 40mm l7e2r; 64956080 gmrs extension piece 80mm jcb6e; 7030-6535 6.5mm low profile hex screw 35mm zk6d; 7030-6530 6.5mm low profile hex screw 30mm z94a1; 7030-6530 6.5mm low profile hex screw 30mm z94a1; it cannot be determined which, if any of these devices may have caused or contributed to the patient's experience.Not returned.
Event or Problem Description
Patient had an index left tha on (b)(6) 2021.Patient presented with infection of left hip.Underwent revision for pji on (b)(6) 2021.Mdm and head components were exchanged.

• 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: brad curtis ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 13691944
• Report Number: 0002249697-2022-00345
• Device Sequence Number: 1944214
• Product Code: MEH
• UDI-Device Identifier: 04546540638977
• UDI-Public: 04546540638977
• Combination Product (Y/N): N
• Initial Reporter State: PA
• 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: Other,Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 03/08/2022

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 Model Number: 1236-2-848
• Device Catalogue Number: 1236-2-848
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/11/2022
• Initial Report FDA Received Date: 03/08/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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: Required Intervention; Hospitalization
• Patient Age: 87 YR
• Patient Sex: Female
• Patient Weight: 51 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White