MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US UNK HIP ACETAB LNR CERMIC; CERAMIC ACETABULAR LINER

Catalog Number UNK HIP ACETABULAR LINER CERAM

Device Problems Fracture (1260); Device Dislodged or Dislocated (2923); Noise, Audible (3273)

Patient Problems Pain (1994); Joint Dislocation (2374); Physical Asymmetry (4573); Insufficient Information (4580)

Event Date 08/08/2023

Event Type  Injury  

Event Description

Article entitled ¿factors influencing noise following primary ceramic-on ceramic total hip arthoplasty¿ written by yibin zhang, yuhang gao, md, yi leng, md, jianzeng zhang, md, chengshuai zhang, mm, and xin qi, md published in the journal of arthoplasty on august 8, 2023 was reviewed.The aim of the study was to hypothesized that patient factors (eg, age, body mass index [bmi], anatomical variation) and implant factors (eg, implant orientation and size) might affect noise production after coc tha.Accordingly, we designed a questionnaire to collect data on noise site, frequency, and duration reported by patients and utilized implant information and imaging data for radiographic analysis with the aim of delineating the characteristics of different types of noise.119 patients (174 hips) were involved in the final analysis.All hips were implanted with corail stems, pinnacle cup, ceramic head, and ceramic liner.Adverse events 55 patients reported implant noise.15 patients reported pain.Cup malpositioning was reported (cup anteversion) leg length discrepancy was reported one patient who reported clicking at 6 months postsurgery experienced 2 episodes of joint dislocation within a year after surgery.Manual manipulation successfully reduced the dislocations, and no further dislocations were reported.Another patient who underwent bilateral tha reported grinding in the left hip 14 months postoperatively.This patient reported that the noise occurred intermittently during walking and was particularly noticeable during squatting.In the 40th month after surgery, the patient experienced a ceramic liner fracture and underwent revision surgery with a cop bearing, after which the noise did not recur.

Manufacturer Narrative

Product complaint # (b)(4).D4: the device catalog number is unknown; therefore, udi is unavailable.The size of the article is too large to attach/submit with the 3500a submission.The citation of the article has been provided below: article entitled ¿factors influencing noise following primary ceramic-on ceramic total hip arthoplasty¿ written by yibin zhang, yuhang gao, md, yi leng, md, jianzeng zhang, md, chengshuai zhang, mm, and xin qi, md published in the journal of arthoplasty on august 8, 2023.This report is being submitted pursuant to the provisions of 21 cfr, part 803 (and/or part 4, as applicable).This report may be based on information which has not been investigated or verified prior to the required reporting date.This report does not reflect a conclusion by depuy synthes, or its employees that the report constitutes an admission that the product, 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 report, a follow-up report will be filed as appropriate.

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.As part of our company quality system process, all devices are manufactured, inspected and distributed to approved specifications.Additional complaint information, monitoring for potential safety signals will be conducted through complaint trending as part of the post-market surveillance.If additional information is made available, the investigation will be updated as applicable.Device history lot: the device lot number is unknown.Therefore, a device history review could not be performed.  if the lot/serial number becomes available, the record will be re-assessed.

• Brand Name: UNK HIP ACETAB LNR CERMIC
• Type of Device: CERAMIC ACETABULAR LINER
• Manufacturer (Section D): DEPUY ORTHOPAEDICS INC US; 700 orthopaedic drive; warsaw IN 46581 0988
• Manufacturer (Section G): JTE WARSAW MFG SITE; 700 orthopaedic drive; warsaw IN
• Manufacturer Contact: kate karberg ; 700 orthopaedic dr.; warsaw, IN 46581-0988 ; 3035526892
• MDR Report Key: 18021244
• MDR Text Key: 326727845
• Report Number: 1818910-2023-21836
• 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
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 10/27/2023

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?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: UNK HIP ACETABULAR LINER CERAM
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 10/16/2023
• Initial Date FDA Received: 10/27/2023
• Supplement Dates Manufacturer Received: 11/09/2023
• Supplement Dates FDA Received: 11/20/2023
• 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: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention