MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US DELTA CER HEAD 12/14 32MM +5; ARTICULEZE HEAD (12/14 TAPER) : HIP CERAMIC FEMORAL HEADS

Catalog Number 136532320

Device Problems Naturally Worn (2988); Noise, Audible (3273)

Patient Problems Pain (1994); Joint Laxity (4526)

Event Date 01/01/2022

Event Type  Injury  

Manufacturer Narrative

Product complaint # (b)(4).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.

Event Description

Surgeon is reporting an inlay luxation.Patient received a hip-tep in another hospital on (b)(6) 2020.A pe lipped liner was inserted.Since (b)(6) 2023, the patient reported crunching and pain in the hip without trauma.Radiologically, the case appeared to be inlay wear.However, intraop inlay dislocation was found.The inlay was plastically deformed.

Manufacturer Narrative

Product complaint (b)(4).Investigation summary : according to the information received, ¿surgeon is reporting an inlay luxation.Patient received a hip-tep in another hospital on (b)(6)2020.A pe lipped liner was inserted.Since (b)(6) 2023, the patient reported crunching and pain in the hip without trauma.Radiologically, the case appeared to be inlay wear.However, intraop inlay dislocation was found.The inlay was plastically deformed.¿ the photo was returned to depuy synthes for evaluation.The depuy synthes team conducted a visual inspection from attachment names (b)(4) intra-op photos, (b)(4) x-ray 1 (b)(6)2023, (b)(4) x-ray 2 (b)(6)2023.Jpgnd (b)(4) x-ray (b)(6)2023.Review of the photographic and x-ray evidence was able to confirm the complaint.The femoral head appears to be in unintended contact with the inner surface of the cup and presents metal transfer, it is not unreasonable to conclude that audible sound would be present.With the information provided is not possible to determine a potential cause at this moment, the mode of failure of the device is multi-factorial and consideration must be given to all other potential influences such as surgical process, patient variables (e.G.Activity level and use), anatomical considerations and patient changes over time.Any conclusions from the investigational input provided have to be placed into context with all other relevant factors the overall complaint was confirmed as the observed condition of the delta cer head 12/14 32mm +5 would contribute to the complained device issue.Based on the investigation findings, it has been determined that no corrective and/or preventative action is proposed.There is no indication that a design or manufacturing issue has caused the reported complaint condition.As part of depuy synthes quality process, all devices are manufactured, inspected, and released to approved specifications.Additional monitoring for any potential safety signals will be conducted through complaint trending and other post-market safety surveillance activities.Device history lot : product description: delta cer head 12/14 32mm +5 product code: 136532320.Lot number: 9615449.1) quantity manufactured: 20 parts.2) date of manufacture: 18-oct-2020.3) any anomalies or deviations identified in dhr: there were no non-conformances associated with this lot.4) expiry date: 30-sep-2025.5) ifu reference: 090200701.

• Brand Name: DELTA CER HEAD 12/14 32MM +5
• Type of Device: ARTICULEZE HEAD (12/14 TAPER) : HIP CERAMIC FEMORAL HEADS
• 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: 18657808
• MDR Text Key: 334727923
• Report Number: 1818910-2024-02543
• Device Sequence Number: 1
• Product Code: LZO
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: K031803
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 02/07/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/07/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 136532320
• Device Lot Number: 9615449
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/03/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/18/2020
• 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
• Treatment: PINN MAR +4 10D 32IDX50OD; UNKNOWN HIP ACETABULAR CUP; UNKNOWN HIP FEMORAL HEAD
• Patient Outcome(s): Required Intervention
• Patient Sex: Female