MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US UNKNOWN HIP FEMORAL STEM

Catalog Number UNK HIP FEMORAL STEM

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

Patient Problems Arrhythmia (1721); Bone Fracture(s) (1870); Hemorrhage/Bleeding (1888); Myocardial Infarction (1969); Pneumonia (2011); Pulmonary Edema (2020); Renal Failure (2041); Impaired Healing (2378)

Event Date 10/21/2022

Event Type  Injury  

Manufacturer Narrative

Product complaint # (b)(4).The device catalog number is unknown; therefore, udi is unavailable.Adverse event problem component code: appropriate term/code not available (g07002) used to capture no findings available.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.Depuy synthes is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on information which depuy synthes has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy synthes or its employees that the report constitutes an admission that the device, 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 medwatch, a follow-up medwatch will be filed as appropriate.

Event Description

This complaint is from a literature source.The following literature cite has been reviewed: holzapfel de, meyer m, thieme m, pagano s, von kunow f, weber m.Delay of total joint replacement is associated with a higher 90-day revision rate and increased postoperative complications.Arch orthop trauma surg.2022 nov 4:1¿8.Doi: 10.1007/s00402-022-04670-4.Epub ahead of print.Pmid: 36333532; pmcid: pmc9638434.Objective and methods: delay of elective surgeries, including total joint replacement (tjr), is a common consequence in the current pandemic.In trauma surgery, postponement is associated with increased complication rates.This study aimed to evaluate the impact of postponement on surgical revision rates and postoperative complications after elective tjr.In a retrospective analysis of 10,140 consecutive patients undergoing primary total hip replacement (thr) or total knee replacement (tkr) between 2011 and 2020, the effect of surgical delay on 90-day surgical revision rate, as well as internal and surgical complication rates, was investigated using the institute's joint registry and data of the hospital administration.Multivariate logistic regression models were used to adjust for confounding variables.All patients received the same standardized treatment protocol for thr or tkr, respectively.Depuy press-fit acetabular components and cementless stems (pinnacle cup, corail stem or trilock stem) were used in all thr procedures.Depuy cemented components (pfc sigma) were used in all tkrs.No patella resurfacing was performed.Results: two thousand four hundred and eighty tjrs patients were identified with a mean delay of 13.5 ± 29.6 days.Postponed tjr revealed a higher 90-day revision rate (7.1-4.5%, p < 0.001), surgical complications (3.2-1.9%, p < 0.001), internal complications (1.8-1.2% p < 0.041) and transfusion rate (2.6-1.8%, p < 0.023) than on-time tjr.Logistic regression analysis confirmed delay of tjrs as independent risk factor for 90-day revision rate [or 1.42; 95% ci (1.18-1.72); p < 0.001] and surgical complication rates [or 1.51; 95% ci (1.14-2.00); p = 0.04].Conclusion: like trauma surgery, delays in elective primary tjr correlates with higher revision and complication rates.Therefore, surgical scheduling should be performed under consideration of the current covid-19 pandemic.Total hips revised: 543.Total knees revised: 441.Internal complications: total 138 - hips 78 - knees 60: *myocardial infarction; *arrhythmia; *pulmonary edema; *pneumonia; *renal insufficiency; *electrolyte derangement; *hemorrhage.Surgical complications: total 225 - hips 144 - knees 81: *fracture; *impaired healing; *unspecified mechanical complications.

• Brand Name: UNKNOWN HIP FEMORAL STEM
• Type of Device: HIP FEMORAL STEM
• Manufacturer (Section D): DEPUY ORTHOPAEDICS INC US; 700 orthopaedic drive; warsaw IN 46581 0988
• Manufacturer (Section G): DEPUY ORTHOPAEDICS, INC. 1818910; 700 orthopaedic dr.; warsaw IN 46581 0988
• Manufacturer Contact: kate karberg ; 700 orthopaedic dr.; warsaw, IN 46581-0988 ; 3035526892
• MDR Report Key: 16477570
• MDR Text Key: 310600165
• Report Number: 1818910-2023-04931
• 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 Health Care Professional
• Type of Report: Initial
• Report Date: 03/03/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/03/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: UNK HIP FEMORAL STEM
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/16/2023
• 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: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention