MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH UNI ADAPTOR SLEEVE V40 TI; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/CERAMIC/POLYMER, CEMENTED OR NON-POROUS

Catalog Number 6519-T-025

Device Problem Unstable (1667)

Patient Problem Injury (2348)

Event Date 10/30/2019

Event Type  Injury  

Manufacturer Narrative

Review of the device history records indicate that devices were manufactured and accepted into final stock with no reported discrepancies.There have been no other events for the lot referenced.If additional information is received, it will be provided in a supplemental report upon completion of the investigation.Not available.

Event Description

Dr.(b)(6) right hip head/sleeve due to patient instability.He revised from a 40 -2.5 to a +4.Original surgery was (b)(6) 2019 by (b)(6).Update (b)(6) 2019 wg: rep provided usage sheets from primary and revision procedures and reported that no further information will be released by the hospital or surgeon.Rep also confirmed he was the acting mps for the primary procedure, and that the log and session files are not available from the july procedure.

• Brand Name: UNI ADAPTOR SLEEVE V40 TI
• Type of Device: PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/CERAMIC/POLYMER, CEMENTED OR NON-POROUS
• Manufacturer (Section D): STRYKER ORTHOPAEDICS-MAHWAH; 325 corporate drive; mahwah NJ 07430
• Manufacturer (Section G): STRYKER ORTHOPAEDICS-CORK; ida industrial estate; carrigtwohill NA
• Manufacturer Contact: juana hiciano ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 9385512
• MDR Text Key: 169876355
• Report Number: 0002249697-2019-03895
• Device Sequence Number: 1
• Product Code: LZO
• UDI-Device Identifier: 04546540608383
• UDI-Public: 04546540608383
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K070885
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,other
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 11/27/2019

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
• Device Operator: Health Professional
• Device Expiration Date: 04/30/2024
• Device Catalogue Number: 6519-T-025
• Device Lot Number: 71167903
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/30/2019
• Initial Date FDA Received: 11/27/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/02/2019
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 72 YR