MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH BOWED CONICAL STEM 18 X 195MM RESTORATION MODULAR HIP SYSTEM; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED

Catalog Number	6276-7-218
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Injury (2348)
Date of Event	10/21/2019
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.Device not returned.
Event or Problem Description
This pi is for the reported revision of the patient's hip.As reported: "dr.Wanted to replace the cone body and head the patient had previously had implanted on (b)(6) 2014, and convert liner to mdm.When trying to separate the cone body from the stem, the extractor piece broke.We had a backup set at the hospital, but the same piece broke again, but he was able to remove the cone body from the stem." update: reason for revision- liner exchange, with head, mdm, and come body exchange as well due to suspicion of infection.This surgery was a revision of a revision.Body side: left.

• Brand Name: BOWED CONICAL STEM 18 X 195MM RESTORATION MODULAR HIP SYSTEM
• Common Device Name: PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED
• Manufacturer (Section D): STRYKER ORTHOPAEDICS-MAHWAH; 325 corporate drive; mahwah NJ 07430
• MDR Report Key: 9335218
• Report Number: 0002249697-2019-03800
• Device Sequence Number: 1724472
• Product Code: LPH
• UDI-Device Identifier: 07613154058792
• UDI-Public: 07613154058792
• Combination Product (Y/N): N
• Initial Reporter State: CT
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2014
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: health professional,other
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 11/18/2019

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 Catalogue Number: 6276-7-218
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/21/2019
• Initial Report FDA Received Date: 11/18/2019
• 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: 68