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 Device Dislodged or Dislocated (2923); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Fall (1848); Foreign Body Reaction (1868); Pain (1994); Synovitis (2094); Joint Dislocation (2374); Joint Laxity (4526)

Event Date 06/09/2023

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

Hcp reported two consecutive revisions of hip pe-inlays.This complaint is about the first revision.The patient fell on her back and buttocks on (b)(6) 2022 and had no issues until (b)(6) 2023 when she began to have pain in the left hip.X-rays showed the femoral head was off center with suspicion of a dislocation.During the revision, joint instability, synovitis, metallosis, a fractured inlay, and dislocation of the head and liner was identified.There were two healed fractures identified ¿ likely caused from the fall previously.Doi: (b)(6) 2021; dor: (b)(6) 2023 (head/liner only).

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 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.

Event Description

Additional information was received: upon further investigation on (bg)(6) 2024, it was discovered, from the x-ray images, that the liner and cup has disassociated based on the positioning of the head inside the cup.

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).Investigation summary - according to the information received, "hcp reported two consecutive revisions of hip pe-inlays.This complaint is about the first revision".The product was not returned to depuy synthes, however photos were provided for review.See attachments ((b)(4) 20210412 x-rays and (b)(4) 20230502 x-rays).The x-ray investigation revealed delta cer head 12/14 32mm +5 not centered at implant site.This condition may lead to a future dislocation of delta cer head 12/14 32mm +5.However, the image quality is poor and no observations pertaining to the nature of the reported event could be identified.Since the device was not returned, a dimensional inspection cannot be performed.The overall complaint was unconfirmed as the observed condition of the delta cer head 12/14 32mm +5 would not 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 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: 09-nov-2019.3) any anomalies or deviations identified in dhr: no.4) expiry date: 31-oct-2024.5) ifu reference: (b)(4) h3.

Manufacturer Narrative

Product complaint # (b)(4).Investigation summary: according to the information received, "hcp reported two consecutive revisions of hip pe-inlays.This complaint is about the first revision".The product was not returned to depuy synthes, however photos were provided for review.See attachments ((b)(4) x-rays and (b)(4) x-rays).The x-ray investigation revealed delta cer head 12/14 32mm +5 not centered at implant site.This condition may lead to a future dislocation of delta cer head 12/14 32mm +5.However, the image quality is poor and no observations pertaining to the nature of the reported event could be identified.Since the device was not returned, a dimensional inspection cannot be performed.The overall complaint was unconfirmed as the observed condition of the delta cer head 12/14 32mm +5 would not 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 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: 09-nov-2019.3) any anomalies or deviations identified in dhr: no.4) expiry date: 31-oct-2024.5) ifu reference: ifu-0902-00-701.

• 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: 18866208
• MDR Text Key: 337223193
• Report Number: 1818910-2024-04887
• Device Sequence Number: 1
• Product Code: LZO
• UDI-Device Identifier: 10603295033448
• UDI-Public: 10603295033448
• 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,Followup,Followup,Followup
• Report Date: 03/04/2024

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?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 136532320
• Device Lot Number: 9332595
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/19/2024
• Initial Date FDA Received: 03/08/2024
• Supplement Dates Manufacturer Received: 04/15/2024; 04/22/2024; 04/23/2024; 05/06/2024; 05/09/2024
• Supplement Dates FDA Received: 04/21/2024; 04/23/2024; 04/25/2024; 05/08/2024; 05/13/2024
• Was Device Evaluated by Manufacturer?: Yes
• 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 32IDX48OD; DELTA CER HEAD 12/14 32MM +5; UNKNOWN HIP FEMORAL STEM
• Patient Outcome(s): Required Intervention
• Patient Sex: Female