MAUDE Adverse Event Report: ENCORE MEDICAL L.P HEAD, FEMORAL, CERAMIC, BILOX DELTA, 32MM NEUTRAL; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/CERAMIC/POLYMER, CEMENTED OR NON-POROUS

Catalog Number 400-03-322

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

Patient Problems Joint Laxity (4526); Muscle/Tendon Damage (4532)

Event Date 03/07/2024

Event Type  Injury  

Event Description

Revision surgery - due to patient fell 3 weeks after surgery and broke her greater trochanter off.Hip was stable but dr decided to lengthen hip while we were in there.

Manufacturer Narrative

Additional reporting on this event will be provided as a supplemental report to this document as soon as it becomes available.

Manufacturer Narrative

See d4 expiration date.Complaint has been evaluated and is similar to previous report number 1644408-2020-01262; 400-03-282, s809 - trauma, revision surgery.If additional information regarding the reported event is submitted at a future date, this investigation will be re-evaluated.

• Brand Name: HEAD, FEMORAL, CERAMIC, BILOX DELTA, 32MM NEUTRAL
• Type of Device: PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/CERAMIC/POLYMER, CEMENTED OR NON-POROUS
• 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: 19029773
• MDR Text Key: 339205706
• Report Number: 1644408-2024-00400
• Device Sequence Number: 1
• Product Code: LZO
• UDI-Device Identifier: 00888912076098
• UDI-Public: 00888912076098
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K082844
• 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,Followup
• Report Date: 05/11/2024

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: 400-03-322
• Device Lot Number: 861B1276
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 03/07/2024
• Initial Date FDA Received: 04/02/2024
• Supplement Dates Manufacturer Received: 04/09/2024
• Supplement Dates FDA Received: 05/11/2024
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 05/04/2023
• 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: 940-02-48D LOT: 798Z1116; 942-01-32D LOT: 616Z1061
• Patient Outcome(s): Required Intervention
• Patient Age: 69 YR
• Patient Sex: Female