MAUDE Adverse Event Report: ENCORE MEDICAL L.P TAPERFILL HIP STEM, LATERAL OFFSET, SIZE 11; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED

Catalog Number 425-97-011

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Joint Dislocation (2374); Joint Laxity (4526)

Event Date 03/08/2024

Event Type  Injury  

Manufacturer Narrative

Complaint has been evaluated and is similar to previous report number 1644408-2021-00516; 425-97-008, s803 - dislocation, s810 - device loosening, revision surgery.If additional information regarding the reported event is submitted at a future date, this investigation will be re-evaluated.

Event Description

Revision surgery - due to dislocation and loosening.

• Brand Name: TAPERFILL HIP STEM, LATERAL OFFSET, SIZE 11
• Type of Device: PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED
• Manufacturer (Section D): ENCORE MEDICAL L.P; 9800 metric blvd; austin TX 78758
• Manufacturer (Section G): ENCORE MEDICAL L.P; 9800 metric blvd; austin TX 78758
• Manufacturer Contact: james mcmahon ; 9800 metric blvd; austin, TX 78758
• MDR Report Key: 19056496
• MDR Text Key: 339550758
• Report Number: 1644408-2024-00424
• Device Sequence Number: 1
• Product Code: LPH
• UDI-Device Identifier: 00888912078696
• UDI-Public: 00888912078696
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K130099
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 04/05/2024

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 Catalogue Number: 425-97-011
• Device Lot Number: 176R2395
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 03/08/2024
• Initial Date FDA Received: 04/06/2024
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 10/20/2023
• 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
• Treatment: 412-02-060 LOT: 007C1063A; 497-28-350 LOT: 634C1259
• Patient Outcome(s): Other
• Patient Age: 57 YR
• Patient Sex: Female