MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US UNK HIP BONE SCREW

Catalog Number UNK HIP BONE SCREW

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

Patient Problems Nerve Damage (1979); Numbness (2415); Thrombosis/Thrombus (4440); Insufficient Information (4580)

Event Date 01/01/2022

Event Type  Injury  

Manufacturer Narrative

Product complaint # (b)(4).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 "short-term effectiveness analysis of one-stage bilateral total hip arthroplasty by direct anterior approach" written by gong dawei, yang yunkang, chen ge, and yin yiran was reviewed.Publication date is unknown.The aim of our study was to compare the effectiveness of one-stage bilateral total hip arthroplasty by direct anterior approach (daa) and by posterolateral approach, and to investigate the application value of daa in one-stage bilateral total hip arthroplasty.From june 2010 to november 2015 - 34 patients underwent simultaneous bilateral hip replacement using daa (group a) and 31 patients who underwent simultaneous bilateral hip replacement using as posterolateral approach (group b).All patients were implanted with either a corail or trilock stem, pinnacle cup (with screws), and ceramic on ceramic or ceramic on poly bearing.Adverse events: group a ¿ 4 hips developed lateral thigh skin numbness due to lateral femoral cutaneous nerve injury, which resolved spontaneously after 3 months without special treatment.Group b ¿ 1 hip developed sciatic nerve contusion, which recovered after nutritional nerve treatment.Group a ¿ 1 hip had intraoperative greater trochanter fracture and was treated with double-strand wire cerclage, which healed 3 months after surgery.Group b ¿ 2 hips had intraoperative femoral fracture and healed after wire banding and 2 hips had hip dislocation due to intraoperative change of body position and were successfully treated with manual reduction under anesthesia.Group a -2 hips had surgical incision exudation and healed after primary joint cavity debridement and drainage (without prosthesis removal) at 7 days after surgery.Group b ¿ 2 hips had posterior venous thrombosis due to bed rest time and recovered after regular anticoagulant therapy.Group b ¿ 3 patients had postoperative difference in the length of lower limbs of more than 1 cm, of which 2 cases were not recovered to the anatomical length, and 1 case was not recovered to the anatomical length unilaterally, with a total of 5 hips abnormal.

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 BONE SCREW
• Type of Device: BONE SCREW
• 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: 14675249
• MDR Text Key: 293853414
• Report Number: 1818910-2022-10730
• 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: 06/13/2022

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 BONE SCREW
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 05/24/2022
• Initial Date FDA Received: 06/13/2022
• Supplement Dates Manufacturer Received: 08/09/2022
• 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