MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US UNK HIP FEMORAL HEAD CERAMIC; CERAMIC FEMORAL HEAD

Catalog Number UNK HIP FEMORAL HEAD CERAMIC

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

Patient Problems Foreign Body Reaction (1868); Unspecified Infection (1930); Thrombosis/Thrombus (4440)

Event Date 04/11/2023

Event Type  Injury  

Manufacturer Narrative

Product complaint # :(b)(4).D4: the device catalog number is unknown; therefore, udi is unavailable.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: alshammari mo, de petrillo g, epure lm, huk ol, zukor dj, antoniou j.Outcomes of ceramic-on-ceramic bearing total hip arthroplasty: a minimum 10-year follow-up study.J arthroplasty.2023 apr 19:s0883-5403(23)00363-7.Doi: 10.1016/j.Arth.2023.04.018.Epub ahead of print.Pmid: 37084924.Objective and methods: authors evaluated 4th generation ceramic bearings in total hip arthroplasty (tha), reviewing long-term (minimum 10-year follow-up) clinical outcomes and ceramic-on-ceramic bearing specific complications to determine implant survival in 273 hips (234 patients).All patients received a depuy cementless porous-coated pinnacle acetabular cup (273 hips) and either a depuy tri-lock (171 hips), s-rom (64 hips), prodigy (20 hips), corail (15 hips), or summit (3 hips) cementless femoral stem.Patients were evaluated clinically and radiographically postoperatively at 6 weeks, 1 year, and every 2 years thereafter.Results: at the latest follow-up, of the 234 patients (273 hips), 8 patients (8 hips) died from causes unrelated to tha arthroplasty and 6 patients (6 hips) had undergone revision surgery.One woman presented with a venous obstruction of the entire lower extremity.She was further diagnosed with a painless pseudotumor.She refused revision surgery following a spontaneous improvement of the venous obstruction and reduction in the pseudotumor size.There were 9 patients (3 men and 6 women) who reported squeaking.Only one of these patients developed squeaking bilaterally.The noise was constantly reproducible in the hips of 5 patients.There were 4 patients who reported occasional squeaking, one of them being unable to reproduce the noise during the follow-up visit.Squeaking started on average at 21.9 months after tha (range, 7.7 to 48.2 months).One of the 5 patients who had constant audible bearings, a 54-year-old woman, underwent revision for squeaking at 5.4 years postoperatively, which included a metal/highly cross-linked polyethylene head and liner change to resolve squeaking.This patient reported that squeaking during gait began after a fall that happened 2 years post-tha.Her cup inclination and anteversion angles pre-revision were 58 degrees and 19 degrees, respectively.Post-revision, the cup inclination and anteversion angles were at 21.5 degrees and 20.1 degrees, respectively.If the acceptable ranges are defined to be 15 degrees to 35 degrees of anteversion, and 35 degrees to 55 degrees of inclination, only 2 (20%) of the 10 squeaking hips were in the acceptable range.However, there was no statistically significant difference in the postoperative values for hhs and ucla survey scores, nor in the inclination and anteversion of the cup between squeakers and non-squeakers.There were 5 hips revised at a mean 4.6 years (range, 0.1 to 7.1).As already noted, one revision was squeaking related.Squeaking was also reported by 8 other patients, but these did not require revision.Other reasons for revision were early infection in 2 cases, stem loosening in 1 case, and stem fracture in 2 cases (no additional details or treatments provided were given by the authors).The survival analysis for any causes for revision as an endpoint was 96.7%.Patients experiencing squeaking are as follows (all possessed 36mm dia.Heads): sex; head; age; complication; inclination; anteversion; malpositioned cup ; f;36;50;squeaking/revised;58.0;19.0;yes.M;36;61;squeaking;40.3;10.9;yes.F;36;57;squeaking;39.8;12.0;yes.F;36;63;squeaking;47.1;13.4;yes.M;36;41;squeaking;48.2;12.3;yes.F;36;57;squeaking;43.0;15.3;no.F;36;50 ;squeaking;39.8;12.0;yes.M;36;44 ;squeaking;33.3;13.0;yes.F;36;47 ;squeaking bilateral;36.0;16.8;no.F;36;46 ;squeaking bilateral;35.7;14.9;yes.Other complication: 1:deep vein thrombosis and pseudotumor.2:early infection.1:femoral stem aseptic loosening.2:femoral stem implant fracture.

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 FEMORAL HEAD CERAMIC
• Type of Device: CERAMIC FEMORAL HEAD
• 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: 17086692
• MDR Text Key: 316848643
• Report Number: 1818910-2023-11891
• Device Sequence Number: 1
• Product Code: LPH
• Combination Product (y/n): N
• Reporter Country Code: CA
• 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: 06/08/2023

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 FEMORAL HEAD CERAMIC
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 05/31/2023
• Initial Date FDA Received: 06/08/2023
• Supplement Dates Manufacturer Received: 06/12/2023
• Supplement Dates FDA Received: 06/12/2023
• 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