MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US DELTA CER HEAD 12/14 36MM +5; ARTICULEZE HEAD (12/14 TAPER) : HIP CERAMIC FEMORAL HEADS

Catalog Number 136536320

Device Problem Degraded (1153)

Patient Problems Foreign Body Reaction (1868); Pain (1994)

Event Date 10/17/2023

Event Type  Injury  

Manufacturer Narrative

Product complaint # (b)(4).D4: the device catalog number is unknown; therefore, udi is unavailable.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

Patient reported pain and x-ray showed lysis around the shaft, and potential partial loosening of the stem.Patient underwent a revision and stem loosening was confirmed and the cone (trunnion) was noted to have completely corroded.The femoral stem was exchanged with a srom stem/sleeve and the femoral head was exchanged.The acetabular cup and liner were not revised and there were no allegations against either implant.Doi: (b)(6) 2021.Dor: (b)(6) 2023.

Event Description

Additional information received.Ae was reported to nca/bfarm by user: "hip-tep left coc pairing because of coxarthrosis on (b)(6) 2021 in neustadt.Persistent pain and radiological loosening of the stem.Preoperative puncture sterile.Stem change on (b)(6)2023.Taper completely massively corroded / metallosis.".

Manufacturer Narrative

Product complaint (b)(4) this report is being submitted pursuant to the provisions of 21 cfr, part 803.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 joint reconstruction, or its employees that the report constitutes an admission that the product, depuy synthes joint reconstruction, or its employees caused or contributed to the potential event described in this report.H10 additional narrative: added: b5, d9, d10 concomitant, h6 health effect - clinical code if information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.Corrected: b3, h3.

Manufacturer Narrative

Product complaint # (b)(4).This report is being submitted pursuant to the provisions of 21 cfr, part 803.This report may be based on information that has not been investigated or verified prior to the required reporting date.This report does not reflect a conclusion by depuy synthes joint reconstruction, or its employees that the report constitutes an admission that the product, depuy synthes joint reconstruction, 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 : the or dispatcher from the hospital reported an explanation of a device.Actually no further information available the delta cer head 12/14 36mm +5 (product code: 136536320 / lot.Number: 9766788) and photo evidence (b)(4) were returned to depuy synthes for evaluation and forwarded to material science for evaluation.Visual analysis revealed that the ceramic femoral head exhibits evidence of what appears to be corrosion byproduct on the interior surface.No other defects were observed.The evidence suggests there was significant movement between the femoral head and hip stem taper over a long period of time.This suggests the ceramic head was not sufficiently seated on the hip stem taper.A dimensional inspection was not performed for the delta cer head 12/14 36mm +5 as it is not applicable to the complaint condition.A manufacturing record evaluation was performed for the finished device [136536320 / 9766788] number, and no non-conformances / manufacturing irregularities related to the malfunction were identified during manufacturing.The overall complaint was confirmed as the investigation found sings of corrosion on the returned ceramic head.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 : 1) quantity manufactured: (b)(4), 2) date of manufacture: 13/may/2021, 3) any anomalies or deviations identified in dhr: none, 4) expiry date: 30/april/2026, 5) ifu reference: 090200701.Device history review : a manufacturing record evaluation was performed for the finished device [136536320 / 9766788] number, and no non-conformances / manufacturing irregularities related to the malfunction were identified during manufacturing.

• Brand Name: DELTA CER HEAD 12/14 36MM +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): CORK MFG & MATERIAL WAREHOUSE; loughbeg ringaskiddy; cork IN
• Manufacturer Contact: kate karberg ; 700 orthopaedic dr.; warsaw, IN 46581-0988 ; 3035526892
• MDR Report Key: 18091573
• MDR Text Key: 327610507
• Report Number: 1818910-2023-22793
• Device Sequence Number: 1
• Product Code: LZO
• UDI-Device Identifier: 10603295033622
• UDI-Public: 10603295033622
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: P070026
• 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,Followup,Followup
• Report Date: 11/08/2023
• 2 Devices were Involved in the Event: 1 2

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: 136536320
• Device Lot Number: 9766788
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/23/2023
• Initial Date FDA Received: 11/08/2023
• Supplement Dates Manufacturer Received: 11/14/2023; 01/18/2024; 03/14/2024
• Supplement Dates FDA Received: 11/28/2023; 01/24/2024; 03/14/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/12/2021
• 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: TRI-LOCK BPS SZ 1 STD OFFSET; UNK HIP FEMORAL SLEEVE SROM
• Patient Outcome(s): Required Intervention
• Patient Age: 50 YR
• Patient Weight: 70 KG