MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US DELTA CER HEAD 12/14 36MM +1.5; ARTICULEZE HEAD (12/14 TAPER) : HIP CERAMIC FEMORAL HEADS

Catalog Number 136536310

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

Patient Problems Foreign Body Reaction (1868); Hypersensitivity/Allergic reaction (1907)

Event Date 10/11/2021

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

On (b)(6) 2012, the patient had a left hip arthroplasty to address osteoarthritis.Depuy components were implanted during this procedure.No mention of manufacturer of cement.On (b)(6) 2021, the patient had a revision left total hip to address mechanical complication of left hip prosthesis.The indications for surgery included, symptoms consistent with metallosis and excessive wear.During the procedure, the surgeon observed gross black tissue staining and a pseudotumor.The surgeon noted that the polyethylene shell completely broken free of the liner and the head was articulating with the cup.There was a large amount of titanium wear debris in the shell.The depuy acetabular cup was retained and the surgeon elected to use a bur to roughen the undersurface of the cup.The surgeon then roughened up the back of the new cup and cemented the competitor cup into the retained depuy cup.The stem, head, and acetabular liner were removed.Doi: (b)(6) 2012, dor: (b)(6) 2021 (left hip).

Manufacturer Narrative

Product complaint # (b)(4).Investigation summary : no device associated with this report was received for examination.An evaluation of the manufacturing record could not be performed as the required product/lot number was not provided to complete the evaluation.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.

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.H10 additional narrative: added: b7 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).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.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).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.

Manufacturer Narrative

Product complaint (b)(4) investigation summary: (b)(6) 2021, the patient had a revision left total hip to address mechanical complication of left hip prosthesis.The indications for surgery included, symptoms consistent with metallosis and excessive wear.During the procedure, the surgeon observed gross black tissue staining and a pseudotumor.The surgeon noted that the polyethylene shell completely broken free of the liner and the head was articulating with the cup.There was a large amount of titanium wear debris in the shell.The depuy acetabular cup was retained and the surgeon elected to use a bur to roughen the undersurface of the cup.The surgeon then roughened up the back of the new cup and cemented the competitor cup into the retained depuy cup.The stem, head, and acetabular liner were removed.Competitor components were implanted during this procedure.Doi:(b)(6) 2012 dor: (b)(6) 2021 (left hip).The product was not returned to depuy synthes, however radiological images were provided for review.See attachment "(b)(4) radiology records ad (b)(6) 2024".The radiological images were reviewed, however they do not represent the reported complaint condition.The images show what appears to be the competitors components that were implanted during the revision of the left hip.Therefore, the investigation could not draw any conclusions about the reported event due to the insufficient evidence provided.The overall complaint was not confirmed as the radiological images provided are not representative of the reported complaint condition.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 : the product investigation found no evidence suspecting an error in the manufacturing or material that would be a contributing factor in the reported allegation(s).A manufacturing records evaluation (mre) was not performed.

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.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.

Event Description

Medical records were received: on (b)(6) 2012, the patient had a left hip arthroplasty to address osteoarthritis.Depuy components were implanted during this procedure.No mention of manufacturer of cement.On (b)(6) 2021, the patient had a revision left total hip to address mechanical complication of left hip prosthesis.The indications for surgery included, symptoms consistent with metallosis and excessive wear.During the procedure, the surgeon observed gross black tissue staining and a pseudotumor.The surgeon noted that the polyethylene shell completely broken free of the liner and the head was articulating with the cup.There was a large amount of titanium wear debris in the shell.The depuy acetabular cup was retained and the surgeon elected to use a bur to roughen the undersurface of the cup.The surgeon then roughened up the back of the new cup and cemented the competitor cup into the retained depuy cup.The stem, head, and acetabular liner were removed.Competitor components were implanted during this procedure.On (b)(6) 2021 the medical records note the patient had multiple surgeries: 9 on the right hip, 3 on the left hip (no specific info).Patient reports having constant pain in the bilateral hips, lumbar spine, and cervical spine.The patient¿s impairments include pain, pelvic alignment issues and decreased function.On (b)(6) 2022, a rehab outpatient communication reports that the patient stated that they had metal poisoning.Doi:(b)(6) 2012 dor: (b)(6) 2021 (left hip).

• Brand Name: DELTA CER HEAD 12/14 36MM +1.5
• 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: 17798426
• MDR Text Key: 324032706
• Report Number: 1818910-2023-19306
• Device Sequence Number: 1
• Product Code: LZO
• UDI-Device Identifier: 10603295033615
• UDI-Public: 10603295033615
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P070026
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date: 09/22/2023
• 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?: No
• Device Operator: Health Professional
• Device Expiration Date: 02/16/2017
• Device Catalogue Number: 136536310
• Device Lot Number: 3425644
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 09/06/2023
• Initial Date FDA Received: 09/22/2023
• Supplement Dates Manufacturer Received: 09/25/2023; 12/15/2023; 01/22/2024; 03/06/2024; 03/11/2024; 03/26/2024
• Supplement Dates FDA Received: 09/26/2023; 12/22/2023; 01/26/2024; 03/07/2024; 03/15/2024; 04/10/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/24/2012
• 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: ALTRX NEUT 36IDX52OD; CORAIL AMT COLLAR SIZE 12; PINN 100 W/GRIPTION 52MM; UNK HIP ACETABULAR CUP PINNACLE; UNK HIP ACETABULAR LINER POLY; UNK HIP FEMORAL STEM CORAIL
• Patient Outcome(s): Required Intervention
• Patient Age: 58 YR
• Patient Sex: Female