MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US UNK REAMER; HIP INSTRUMENTS: REAMER

Catalog Number UNK REAMER

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

Patient Problem Bone Fracture(s) (1870)

Event Date 06/15/2020

Event Type  Injury  

Event Description

This complaint is from a literature source.The following literature cite has been reviewed: li j, ji q, ni m, zheng q, sun j, zhang g.Management of intraoperative acetabular fracture in primary total hip arthroplasty.Bmc musculoskelet disord.2020 jun 15;21(1):383.Doi: 10.1186/s12891-020-03356-5.Pmid: 32539748; pmcid: pmc7296652.Objective and methods: intraoperative acetabular fracture (iaf) is a rare complication of primary total hip arthroplasty (tha).The previous reports have lacked a sufficiently large number of subjects to allow for an analysis of the causes and appropriate treatment of this problem.The purpose of the present study was to retrospectively review a larger consecutive series of patients who had sustained iaf of the acetabulum during primary tha.The authors retrospectively reviewed 24 patients who were all treated with a posterolateral approach using uncemented components that sustained intraoperative acetabular fractures between 2015 and 2018 (16 females and 8 males).The authors utilized 13 pinnacle cups and liners and 11 competitor acetabular components.The femoral components consisted of 8 srom stems with sleeves, 4 corail stems, and 13 competitor stem/head combinations.Twenty patients (83.3%) underwent supplemental screw fixation, of which 2 patients were treated with steel plate fixation.Two patients' femoral heads were used as a graft.In 4 patients (16.7%), the acetabular components were judged to be stable despite the fracture and no additional treatment was performed.All patients were evaluated clinically with harris hip scores (hhs) and radiographically with serial x-rays which follow up for a mean period of 34.0 ± 12.6 months.The authors concluded that intraoperative acetabular fractures are rare complications of tha, and most commonly occur during the implantation of the acetabular components.It is necessary to prevent the occurrence of fractures as much as possible even if the fractures are found during the operation.It should be noted that patients with ankylosing spondylitis involving hip joints during tha surgery must be careful to prevent iafs during dislocation and pre-osteotomy.Of note: the authors provide a table of cups associated with patient specifics.The other complications noted in the article, as well as the one fracture sustained during reaming, are not provided with device manufacturer or patient specifics.These events will be captured with a quantity of one, as the actual number of depuy devices associated with these events is unknown.This complaint will exclude events associated with known competitor products.Lot, model and catalog number are not available, but the suspected depuy device possibly associated with reported adverse events: pinnacle cup, corail stems, srom stems and sleeves, and unknown depuy liners and femoral heads.Adverse event(s) and provided interventions associated with depuy devices: patient specific results: case 2: patient received a primary tha to treat avn.Patient sustained an intraoperative posterior acetabular wall fracture during cup implantation which was stabilized with 4 screws.Case 4: patient received a primary tha to treat avn.Patient sustained an intraoperative posterior acetabular wall fracture during cup implantation which was stabilized with 3 screws.Case 5: patient received a primary tha to treat avn.Patient sustained an intraoperative posterior and medial acetabular wall fracture during cup implantation which was stabilized with 9 screws and a plate.Images located in fig 2 (pp3) case 7: patient received a primary tha to treat ankylosing spondylosis.Patient sustained an intraoperative posterior acetabular wall fracture during cup implantation which was stabilized with 3 screws and a plate.Case 8: patient received a primary tha to treat ankylosing spondylosis.Patient sustained an intraoperative acetabular anterior column fracture during cup implantation which was stabilized with 1 screw.Case 10: patient received a primary tha to treat ddh.Patient sustained an intraoperative posterior acetabular wall fracture during cup implantation which was stabilized with 1 screw.Case 13: patient received a primary tha to treat avn.Patient sustained an intraoperative medial acetabular wall fracture during cup implantation which was stabilized with 1 screw.Case 14: patient received a primary tha to treat oa.Patient sustained an intraoperative posterior acetabular wall fracture during cup implantation which was stabilized with 14 screws.Case 19: patient received a primary tha to treat avn.Patient sustained an intraoperative posterior acetabular wall fracture during cup implantation which was stabilized with 2 screws.Case 20: patient received a primary tha to treat ddh.Patient sustained an intraoperative posterior and superior acetabular wall fracture during cup implantation which was stabilized with 2 screws.Images located in fig 4 (pp4) case 21: patient received a primary tha to treat ddh.Patient sustained an intraoperative posterior acetabular wall fracture during cup implantation which was stabilized with 3 screws.Case 22: patient received a primary tha to treat ddh.Patient sustained an intraoperative posterior and medial acetabular wall fracture during cup implantation which was stabilized with 2 screws.Case 24: patient received a primary tha to treat ankylosing spondylosis.Patient sustained an intraoperative anterior acetabular wall fracture during cup implantation which was stabilized with 2 screws.Non-patient specific results: 1 acetabular fracture sustained during reaming, treated with internal fixation.1 intraoperative trochanter fracture treated with cerclage wiring 1 delayed wound healing that resolved after one-year of unspecified invasive treatment.1 postoperative dislocation treated with open reduction.

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.

Manufacturer Narrative

Product complaint # (b)(4).Investigation summary : no device was received for examination, therefore the reported event could not be confirmed.Depuy considers the investigation closed.Should additional information be received, the information will be reviewed and the investigation will be re-opened as necessary.Device history lot : a worldwide complaint database search was not possible as the required product code and lot number were not provided.

• Brand Name: UNK REAMER
• Type of Device: HIP INSTRUMENTS: REAMER
• Manufacturer (Section D): DEPUY ORTHOPAEDICS INC US; 700 orthopaedic drive; warsaw IN 46581 0988
• Manufacturer (Section G): DEPUY ORTHOPAEDICS 1818910; 700 orthopaedic dr; warsaw IN 46581 0988
• Manufacturer Contact: kara ditty-bovard ; 700 orthopaedic dr.; warsaw, IN 46581-0988 ; 6107428552
• MDR Report Key: 12688328
• MDR Text Key: 282196021
• Report Number: 1818910-2021-23371
• Device Sequence Number: 1
• Product Code: HTO
• 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: 10/11/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/25/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: UNK REAMER
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/30/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention