MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US UNK KNEE STEM LPS

Catalog Number UNK KNEE STEM LPS

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 01/01/2023

Event Type  Injury  

Event Description

Drra was received.The purpose of this study was to provide a descriptive assessment, using real-world data (rwd), on the use of depuy synthes limb preservation system (lps) and attune revision lps.Patients were identified in the premier healthcare database (phd) between january 1, 2001 and march 31, 2023.625 patients were implanted with lps implants.16 patients were implanted with the lps hip subgroup, femoral stems (cemented stem, 31.3%; porous stem, 43.8%) and segmental components (68.8%) were also commonly used; 1 patient (6.3%) had a distal femur, and 2 patients (12.5%) had a universal tibial hinged insert.207 patients were implanted with the lps knee subgroup , other components frequently observed were the universal tibial hinged insert (54.1%), femoral sleeve adaptors (33.8%), segmental components (32.9%), and femoral stems (cemented stem, 28.5%; porous stem, 5.3%); 1 patient (0.5%) had a proximal femoral body, 1 patient (0.5%) had a proximal tibial replacement component, and 8 patients (3.9%) had the attune revision lps insert.260 patients were implanted had the universal tibial hinged insert (comprising the universal tibial hinged insert only subgroup).142 patients were implanted without either a proximal femoral body or distal femur -other components observed for this subgroup were femoral sleeve adaptors (12.3%), segmental components (9.2%), and femoral stems (cemented stem, 3.5%; porous stem, 0.4%); 1 patient (0.4%) had a proximal tibial replacement component (0.4%), and 1 patient had a hinge pin (0.4%).183 patients were implanted with attune revision implants.183 patients were implanted with attune revision.Attune revision lps cohort included 183 patients with inserts and 2 patients with sleeve adaptors.Additionally, this cohort included patients with lps femoral stems (cemented stem, 4.3%; porous stem, 4.3%) and lps segmental components (3.3%).Outcomes were based on subsequent surgery within 24 months.Lps hip: 3 for infection, 3 for mechanical complications (dislocation), and 1 for other complication (osteomyelitis).Lps knee: 55 for infection, 27 for mechanical complication (dislocation or implant loosening), and 34 for other complications.Insert only: 70 for infection, 19 for mechanical complication, 34 for other complications.Other lps: 39 for infection, 16 for mechanical complication, and 20 for other complications.Attune revision: 31 for infection, 11 for mechanical complication (dislocation or loosening), and 23 for other complications.

Manufacturer Narrative

Product complaint # (b)(4).D4: the device catalog number is unknown; therefore, udi is unavailable.Investigation summary: no device associated with this report was received for examination.An evaluation of the manufacturing record could not be performed as the required product/lot number was not provided to complete the evaluation.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.B3: date of event is an unknown date.H6: component code: appropriate term/code not available (g07002) used to capture no findings available.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.

• Brand Name: UNK KNEE STEM LPS
• Type of Device: KNEE STEM
• Manufacturer (Section D): DEPUY ORTHOPAEDICS INC US; 700 orthopaedic drive; warsaw IN 46581 0988
• Manufacturer (Section G): JTE WARSAW MFG SITE; 700 orthopaedic drive; warsaw IN
• Manufacturer Contact: kate karberg ; 700 orthpaedic dr.; warsaw, IN 46581 ; 3035526892
• MDR Report Key: 17930295
• MDR Text Key: 325604167
• Report Number: 1818910-2023-20897
• Device Sequence Number: 1
• Product Code: LPH
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 10/13/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/13/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: UNK KNEE STEM LPS
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 09/29/2023
• 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
• Treatment: UNK ATTUNE KNEE TIBIAL INSERT; UNK HIP FEMORAL STEM LPS; UNK KNEE FEMORAL LPS; UNK KNEE STEM LPS; UNK KNEE STEM LPS; UNK KNEE TIBIAL INSERT LPS; UNK KNEE TIBIAL INSERT LPS; UNKNOWN HIP FEMORAL HEAD; UNKNOWN KNEE TIBIAL TRAY
• Patient Outcome(s): Required Intervention