MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH RESTORATION ADM X3 INS 28/54; PROSTHESIS, HIP, SEMI-CONSTRAINED, UNCEMENTED, METAL / POLYMER, NON-POROUS, CALC

Model Number	1236-2-854
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Unspecified Infection (1930)
Date of Event	08/30/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
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.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.The following devices were also listed in this report: modular dual mobility insert; cat # 626-00-48g; lot # unknown.Delta v-40 ceramic head 28/0; cat # 6570-0-128; lot # unknown.Exeter v40 stem 50mm no 4; cat # 0580-1-504; lot # g7153273.Restoration anatomic shell size 72 right; cat # 504-02-72g-r; lot # 4w29ed.Gap plate screws; cat # 2080-0050; lot # vv6rrx.Gap plate screws; cat # 2080-0050; lot # 1j59tw.Gap plate screws; cat # 2080-0035; lot # 775tty2.Gap plate screws; cat # 2080-0035; lot # 775ty2.It cannot be determined which, if any of these devices may have caused or contributed to the patient's experience.
Event or Problem Description
As reported: "pt.Presented with a draining surgical-wound, following a [right] hip revision [of competitor devices] a couple weeks ago.Dr.Performed an i&d and swapped out some components as per his i&d/revision protocol.No complaints have been filed against the implants themselves." spoke to rep: infection was suspected.No further information will be released by the hospital or surgeon.

• Brand Name: RESTORATION ADM X3 INS 28/54
• Common Device Name: PROSTHESIS, HIP, SEMI-CONSTRAINED, UNCEMENTED, METAL / POLYMER, NON-POROUS, CALC
• Manufacturer (Section D): STRYKER ORTHOPAEDICS-MAHWAH; 325 corporate drive; mahwah NJ 07430
• MDR Report Key: 12514089
• Report Number: 0002249697-2021-01610
• Device Sequence Number: 16395998
• Product Code: MEH
• UDI-Device Identifier: 04546540639004
• UDI-Public: 04546540639004
• Combination Product (Y/N): N
• Initial Reporter State: FL
• 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,other
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 09/22/2021

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: 03/31/2026
• Device Model Number: 1236-2-854
• Device Catalogue Number: 1236-2-854
• Device Lot Number: 512465
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 08/30/2021
• Initial Report FDA Received Date: 09/22/2021
• 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: 69 YR