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 Noise, Audible (3273)

Patient Problem Foreign Body Reaction (1868)

Event Date 06/09/2022

Event Type  Injury  

Manufacturer Narrative

Product complaint#: (b)(4).Additional event information: the english transcribed medical records were revised by clinician.On (b)(6) 2018, the patient had a minimally invasive cement-free hip tep left to address dysplasia coaxarthrosis left.The following implants were implanted: pinnacle grip 100 pan 52mm lot: 8674078, pinnacle/altrx inlay 36mm x 52mm lot: hu3859, apex hole lock for duraloc/pinnacle pans lot: d18051223, corail hip amt std.Size 11 lot:5317729, biolox delta ceramic head +1.5 36mm 12/14 lot:8838268.On (b)(6) 2022, the patient had a revision to address inlay dislocation, metallosis in case of ladle and inlay abraision (head/liner).During the revision, the surgeon observed severe scarring.The head/liner were revised.The following implants were implanted: pinnacle /altrx inlay 36mm x 52mm 1221.36.052 depuy lot code: jw3785, ceramax ts rev hip head 12/14 36 +5mm lot code: 9847596 (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

Patient of (b)(6) (= 2nd revision on (b)(6) 2024) was revised before.This complaint: (b)(4) covers the first revision: revision of inlay and hip head because of inlay dislocation left side.Soft tissue metallosis with cup and inlay wear.

Manufacturer Narrative

Product complaint # (b)(4).Investigation summary : no device associated with this report was received for examination.A manufacturing record evaluation was performed for the finished device product code:136536310, lot - number: 8838268, and no non-conformances / manufacturing irregularities were identified.Dhr review: product code 136536310, work order (b)(4), was manufactured on 15-jun-2018.(b)(4) parts were manufactured per specification and all raw materials met specification.Scrap: there was 0 scrap associated with this work order reprocessing: there was 0 material reprocessing reports (mrr) associated with this lot.Non-conformance: there was 0 non-conformance associated with this lot.Coc review: certificate of conformance review for (b)(4) parts, product code delta cer head artic, work order (b)(4) did meet specification.Complaint confirmation: non-verifiable conclusion: due to no similar failures found in the dhr review, the root cause of the complaint cannot be determined.Should further information come available that impacts the findings in this investigation it will be reopened 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 : a manufacturing record evaluation was performed for the finished device product code:136536310, lot - number: 8838268, and no non-conformances / manufacturing irregularities were identified.

• 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 ; 3035526892
• MDR Report Key: 18717366
• MDR Text Key: 335521387
• Report Number: 1818910-2024-03049
• Device Sequence Number: 1
• Product Code: LZO
• UDI-Device Identifier: 10603295033615
• UDI-Public: 10603295033615
• 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
• Report Date: 02/15/2024

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 Expiration Date: 05/31/2023
• Device Catalogue Number: 136536310
• Device Lot Number: 8838268
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/05/2024
• Initial Date FDA Received: 02/15/2024
• Supplement Dates Manufacturer Received: 02/23/2024
• Supplement Dates FDA Received: 02/26/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/15/2018
• 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
• Treatment: ALTRX NEUT 36IDX52OD.; UNKNOWN HIP ACETABULAR CUP.
• Patient Outcome(s): Required Intervention
• Patient Age: 63 YR
• Patient Sex: Female