MAUDE Adverse Event Report: DEPUY INTERNATIONAL LTD - 8010379 UNK HIP FEMORAL STEM C-STEM

Catalog Number UNK HIP FEMORAL STEM C-STEM

Device Problems Loss of or Failure to Bond (1068); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Unspecified Infection (1930); Insufficient Information (4580)

Event Date 11/22/2022

Event Type  Injury  

Manufacturer Narrative

Product complaint # (b)(4).D4: the device catalog number is unknown; therefore, udi is unavailable.This report is being submitted pursuant to the provisions of 21 cfr, part 803 (and/or part 4, as applicable).This report may be based on information which has not been investigated or verified prior to the required reporting date.This report does not reflect a conclusion by depuy synthes, or its employees that the report constitutes an admission that the product, depuy synthes, or its employees caused or contributed to the potential event described in this report.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.

Event Description

Article entitled ¿periprosthetic femoral fractures around the original cemented polished triple tapered c stem femoral implant: a consecutive series of 500 primary total hip arthroplasties with an average follow up of 15 years¿ written kwaku baryeh, chao wang, and david h.Sochart published in archives of orthopaedic and trauma surgery on (b)(6) 2022 was reviewed.This study reports the long-term rate of pff with the original triple-tapered c-stem femoral implant.500 hips (455 patients were included in the initial study).All patients were implanted with a cstem and competitor cement was used.There was no mention of the acetabular cup or liner.14 c-stems (13 patients) reported revisions ¿ 1 for late sepsis, 3 for aspectic loosening, 1 for ppf, and 10 for loose acetabular cup.Adverse event(s) that are possibly associated with unknown femoral c-stem -1 patient with infection.Treated with revision.-3 patients with stem loosening (unknown interface).Treated with revision.Adverse event(s) that are possibly associated with unknown femoral head -1 patient with infection.Treated with revision.180 c-stems (159 patients) were included in the final cohort.Adverse event(s) and provided interventions possibly associated with unidentified unknown femoral c-stem (table 3): patient #1 ¿ a 68-year-old male experienced a ppf on the right hip.The stem was noted to be in varus.Treatment was orif.Patient #2 ¿ a 79-year-old male experienced a ppf on the left hip.Treatment was revision.Patient #3 ¿ a 78-year-old female experienced a ppf on the right hip.Treatment was orif.Patient #4 ¿ a 87-year-old female experienced a ppf on the right hip.Treatment was orif.Patient #5 ¿ a 67-year-old male experienced a ppf on the right hip.Treatment was orif.Patient #6 ¿ a 71-year-old female experienced a ppf on the right hip.Treatment was orif.Patient #7 ¿ a 68-year-old female experienced a ppf on the right hip.The stem was noted to be in varus.Treatment was revision.

Manufacturer Narrative

Product complaint (b)(4).Investigation summary; no device associated with this report was received for examination.This complaint was opened to document complaints derived through a journal article review.Follow-ups were done to try and obtain additional information from the author of the journal article.No further information was received.As part of our company quality system process, all devices are manufactured, inspected, and distributed to approved specifications.Additional complaint information monitoring for potential safety signals will be conducted through complaint trending as part of the post-market surveillance.If additional information is made available, the investigation will be updated as applicable.Device history lot; the device lot number is unknown, therefore a device history review could not be performed.If the lot/serial number becomes available, the record will be re-assessed.

• Brand Name: UNK HIP FEMORAL STEM C-STEM
• Type of Device: FEMORAL STEM
• Manufacturer (Section D): DEPUY INTERNATIONAL LTD - 8010379; st. anthony's road; leeds LS11 8DT; UK LS11 8DT
• Manufacturer (Section G): JTE WARSAW MFG SITE; 700 orthopaedic drive; warsaw IN
• Manufacturer Contact: kate karberg ; 700 orthopaedic dr.; warsaw, IN 46581-0988 ; 3035526892
• MDR Report Key: 19180380
• MDR Text Key: 341018913
• Report Number: 1818910-2024-09067
• Device Sequence Number: 1
• Product Code: LPH
• Combination Product (y/n): N
• Reporter Country Code: GM
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Literature,Health Professional
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 04/25/2024

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?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: UNK HIP FEMORAL STEM C-STEM
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 04/15/2024
• Initial Date FDA Received: 04/25/2024
• Supplement Dates Manufacturer Received: 05/01/2024
• Supplement Dates FDA Received: 05/01/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention