MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US UNK HIP ACETABULAR CUP PINNACLE

Catalog Number UNK HIP ACETABULAR CUP PINNACL

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

Patient Problems Wound Dehiscence (1154); Anemia (1706); Hemorrhage/Bleeding (1888); Unspecified Infection (1930); Thrombosis/Thrombus (4440); Heart Failure/Congestive Heart Failure (4446); Insufficient Information (4580)

Event Date 10/01/2020

Event Type  Injury  

Manufacturer Narrative

Product complaint # (b)(4).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

Article entitled " safety and efficacy of total hip arthroplasty in hypothyroid patients¿ written by yuan mingcheng, xiao qiang, ding zichuan, ling tingxian, and zhou zongke published in chinese journal of reparative and reconstructive in october of 2020 was reviewed.The purpose was to summarize the safety of total hip arthroplasties in patient with hypothyroidism.There were two groups of patients (63 hips in each group).All patients were implants with a pinnacle cup and corail femoral stem.Adverse events: 9 patients underwent transfusion due to blood loss.2 patients had post-op liver dysfunction - after intravenous drip of reduced glutathione for injection, the liver function returned to normal on the next day.3 patients had post-op heart failure - the patients returned to normal after reducing the amount of fluid infusion and slowing down the rate of fluid infusion.1 patient had a pulmonary infection, and 1 patient had a urinary infection that were cured after anti-infective treatment with antibiotics.3 patients had wound complications which were healed after infrared lamp treatment.105 patients had post-op anemia ¿ treatment not noted.12 patients had post-op dvt ¿ treatment not noted.1 patient was readmitted due to hip adduction and internal rotation dislocation, and was discharged smoothly after successful bedside manual reduction.1 patient sustained an infection.Prosthesis removal + antibiotic bone cement provisional prosthesis implantation.

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.Device history lot : a manufacturing record evaluation (mre), was not possible because the required lot code was not provided.

• Brand Name: UNK HIP ACETABULAR CUP PINNACLE
• Type of Device: HIP ACETABULAR CUP
• 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 orthpaedic dr.; warsaw, IN 46581 ; 3035526892
• MDR Report Key: 15189264
• MDR Text Key: 297487193
• Report Number: 1818910-2022-15363
• Device Sequence Number: 1
• Product Code: LPH
• Combination Product (y/n): N
• Reporter Country Code: CH
• 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,Followup
• Report Date: 08/08/2022

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: UNK HIP ACETABULAR CUP PINNACL
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 07/25/2022
• Initial Date FDA Received: 08/08/2022
• Supplement Dates Manufacturer Received: 08/25/2022
• Supplement Dates FDA Received: 08/25/2022
• 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