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

Catalog Number UNK HIP FEMORAL STEM

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

Patient Problems Ossification (1428); Pulmonary Embolism (1498); Arrhythmia (1721); Bone Fracture(s) (1870); Urinary Tract Infection (2120); Joint Laxity (4526); Unspecified Tissue Injury (4559); Physical Asymmetry (4573); Insufficient Information (4580)

Event Date 01/01/2021

Event Type  Injury  

Manufacturer Narrative

Product complaint # pc-(b)(4).

Event Description

Article entitled: ¿which is more suitable for conversion to hip arthroplasty after failure of dynamic hip screws or proximal femoral nail anti-rotation for stable intertrochanteric fractures in the elderly?¿, by zhang tianyi, et.Al., zhongguo zuzhi gongcheng yanjiu.2021;25(33):5335-5340, has been reviewed.Authors sought to evaluate the impact of two treatments, dynamic hip screw versus proximal femoral nail anti-rotation in treatment of non-displaced intertrochanteric hip fractures, with respect to subsequent conversion of the hip to a total hip arthroplasty following the prior treatment¿s failure.Their results identified that conversion to hip arthroplasty after failed dynamic hip screw treatment has a higher orthopedic complication rate than conversion to hip arthroplasty after failed proximal femoral nail anti-rotation (32% vs.13.7%).The study followed 50 patients who were in the dynamic hip screw group, and 52 patients in the proximal femoral nail anti rotation group, both groups having been subsequently treated with j&j total hip arthroplasty (ceramic head on hxlpe liner, with titanium stem and cups: product specifics were not provided, nor was it indicated in which cases bone cement was utilized).The dynamic hip screw and proximal femoral nail systems were non-j&j products.The following post-op complications were observed with respect to the combined groups after their j&j total hip replacements (number of individuals, followed by the complication): 9: postoperative periprosthetic fracture 2: prosthesis instability 2: hip dislocation 1: leg length asymmetry 1: implant loosening 1: heterotopic ossification 1: periprosthetic loosening 1: abductor muscle group dysfunction 5: urinary tract infections 2: pulmonary embolism 1: pressure sore 1: atrial fibrillation specifics of complications nor their treatments were provided in the article.

Manufacturer Narrative

Product complaint # (b)(4).Investigation summary
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> 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
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> a manufacturing record evaluation (mre), was not possible because the required lot code was not provided.

• 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: 14733643
• MDR Text Key: 294401410
• Report Number: 1818910-2022-11128
• 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: 06/17/2022

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?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: UNK HIP FEMORAL STEM
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 06/03/2022
• Initial Date FDA Received: 06/17/2022
• Supplement Dates Manufacturer Received: 08/08/2022
• Supplement Dates FDA Received: 08/09/2022
• 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