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	Wound Dehiscence (1154)
Date of Event	03/23/2021
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: delta v-40 ceramic head 28/+4; cat # 6570-0-228; lot # 81331602.Modular dual mobility insert; cat # 626-00-48g; lot # 82828203.Trochanteric grip plate with 2; cat # 6704-3-082; lot # g7959821.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 to the ed with a draining surgical-wound.Previous surgery was a [right] hip-revision on (b)(6) 2021.Surgeon found the drainage was stemming from a tract that lead down to the joint.Surgeon swapped out the biolox femoral-head and mdm components as part of his i&d protocol.Also, the dall-miles troch plate and dall-miles cables were removed." spoke to rep: infection is not suspected.

• 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: 11675057
• Report Number: 0002249697-2021-00689
• Device Sequence Number: 3160095
• 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): 04/15/2021

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: 06/30/2025
• Device Model Number: 1236-2-854
• Device Catalogue Number: 1236-2-854
• Device Lot Number: 482629
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/23/2021
• Initial Report FDA Received Date: 04/15/2021
• 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: 74 YR