MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US ALTRX NEUT 36IDX52OD; PINNACLE HIP SYSTEM : HIP POLY ACETABULAR LINERS

Catalog Number 122136052

Device Problem Device Dislodged or Dislocated (2923)

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

Event Date 12/17/2023

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

"the patient did a lunge step ten days ago.Since then she has had pain, movement restrictions, and noises in her left hip.Condition after hip joint implantation in 2018.Revision for inlay dislocation in (b)(6) 2022 (inlay change size 52 standard)".

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

Additional information was received: on (b)(6) 2018, the patient had a minimally invasive cement-free hip tep left to address dysplasia coaxarthrosis left.On (b)(6) 2022, the patient had a revision to address inlay dislocation, metallosis in case of ladle and inlay abrasion (head/liner) prior to the surgery, the patient reported 6 months subluxation phenomena, recurrent falls, squeaking sound, restrictive movement and pain of left hip.During the revision, the surgeon observed severe scarring.(b)(6) 2024, the patient had a revision with pan change left along with synovectomy of metallosis, pain change.The patient had a twice inlay luxation for cup retention.The patient had a revision, debridement, during the revision, the surgeon observed that the entire joint was black, the liner was only in the front of the cup (disassociated).The head was not luxated, the inlay had come loose for the 2nd time from the enclosed cement-free cup during a sideways step and was subluxated to mediocaudal.The head was still in the cup.The cup position was regular, no cup loosening, no migration.A purely mechanical problem that the inlay did not hold in the cup.There were no report of surgical delay.

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: it was reported that hcp is reporting to nca/ bfarm: "the patient did a lunge step ten days ago.Since then she has had pain, movement restrictions, and noises in her left hip.Condition after hip joint implantation in 2018.Revision for inlay dislocation on (b)(6) 2022 inlay change size 52 standard the product was returned to depuy synthes for evaluation.The depuy synthes team conducted a visual inspection of the returned device.Visual inspection of the returned sample revealed that several anti rotational devices have been sheared off from the altrx neut 36idx52od.Additionally, the rim of the liner present deformation.Based on the observed damage on the liner it is reasonable to conclude that the liner disassociated from the cup.There is no indication that a design or manufacturing issue has caused or contributed to the reported event.Although the liner failure cannot be traced to design or manufacturing, a definite root cause cannot be established due to there being multiple factors that may influence eccentric loading.Consideration must be given to all 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.It is highly recommended to the patient to consult with their healthcare professional for further assessment.A functional test was not performed as it is not applicable to the complaint condition.A dimensional inspection was unable to be performed due to post manufacturing damage.The overall complaint was confirmed as the observed condition of the altrx neut 36idx52od 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: altrx neut 36idx52od.Product code: 122136052.Lot number: jw3785.1) quantity manufactured: (b)(4) pieces.2) date of manufacture: 2022-04-04.3) any anomalies or deviations identified in dhr: no-non conformance's were identified.4) expiry date: 2027-03-31.5) ifu reference: 090200701 ifu tot.

• Brand Name: ALTRX NEUT 36IDX52OD
• Type of Device: PINNACLE HIP SYSTEM : HIP POLY ACETABULAR LINERS
• Manufacturer (Section D): DEPUY ORTHOPAEDICS INC US; 700 orthopaedic drive; warsaw IN 46581 0988
• Manufacturer (Section G): DEPUY ORTHOPAEDICS, INC. 1818910; 700 orthopaedic dr.; warsaw IN 46581 0988
• Manufacturer Contact: kate karberg ; 700 orthopaedic dr.; warsaw, IN 46581 ; 3035526892
• MDR Report Key: 18730154
• MDR Text Key: 335702741
• Report Number: 1818910-2024-03638
• Device Sequence Number: 1
• Product Code: LPH
• UDI-Device Identifier: 10603295016328
• UDI-Public: 10603295016328
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: K102423
• 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: 02/19/2024

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: 122136052
• Device Lot Number: JW3785
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/31/2024
• Initial Date FDA Received: 02/19/2024
• Supplement Dates Manufacturer Received: 03/28/2024; Not provided; 04/25/2024
• Supplement Dates FDA Received: 04/01/2024; 04/19/2024; 04/25/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/04/2022
• 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: APEX HOLE ELIM POSITIVE STOP.; DLT TS CER HD 12/14 36MM +5.0.; PINN 100 W/GRIPTION 52MM.
• Patient Outcome(s): Required Intervention
• Patient Sex: Female