MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US PINN SECTOR W/GRIPTION 52MM; PINNACLE HIP SYSTEM : HIP METAL ACETABULAR CUPS

Catalog Number 121732052

Device Problem Use of Device Problem (1670)

Patient Problem Foreign Body Reaction (1868)

Event Date 11/06/2023

Event Type  Injury  

Event Description

Patient required hip acetabular revision.In situ implants were identified as dislodged on x-ray.Surgeon surmised likely dislocation was cause by improper placement on initial surgery.Surgeon had to clear major metalosis from joint space and acetabular region prior to revising the join with pdm.

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

Additional information receive.A.Please confirm, was the revision surgery happened successfully? if yes, please provide the details.Yes, this revision surgery was successful.Surgeon implanted new gription cup with pinnacle dual mobility construct.The reason was, he wanted to protect against future dislocation post op.He also implanted a revision ceramic head onto the in situ stem.The stem was not revised.

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 - patient required hip acetabular revision.In situ implants were identified as dislodged on x-ray.Surgeon surmised likely dislocation was cause by improper placement on initial surgery.Surgeon had to clear major metalosis from joint space and acetabular region prior to revising the join with pdm the product was not returned to depuy synthes, however photos were provided for review.See attachment "(b)(4) source data xray image with reps response".From the only x-ray provided the anteversion angle of the pinn sector w/gription 52mm seems to be close to 0°, per pinnacle hip solutions surgical technique the targeted shell anteversion should be 15-20 dreegres taking into acount local soft tissue and anatomic landmarks.Using shell and liner trials in conjunction with the femoral component trials aid in ensuring optimum position of the components.The mode of failure of the device is multi-factorial and consideration must be given to all other 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.As the device was not returned, an as-received condition could not be assessed, and a dimensional inspection and document/specification review were not completed.The overall complaint was confirmed.As the observed condition of the [pinn sector w/gription 52mm] would contribute to the complained device issue.  with the information provide dis not possible to estalbish a potential cause, however 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 - 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.

• Brand Name: PINN SECTOR W/GRIPTION 52MM
• Type of Device: PINNACLE HIP SYSTEM : HIP METAL ACETABULAR CUPS
• 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: 18143091
• MDR Text Key: 328197417
• Report Number: 1818910-2023-23328
• Device Sequence Number: 1
• Product Code: KWA
• UDI-Device Identifier: 10603295010302
• UDI-Public: 10603295010302
• Combination Product (y/n): N
• Reporter Country Code: NZ
• PMA/PMN Number: K093646
• 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
• Report Date: 11/15/2023

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: 121732052
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/05/2023
• Initial Date FDA Received: 11/15/2023
• Supplement Dates Manufacturer Received: 11/16/2023; 02/02/2024
• Supplement Dates FDA Received: 11/23/2023; 02/02/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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: DLT TS CER HD 12/14 32MM +5; PINN MAR NEUT 32IDX52OD
• Patient Outcome(s): Required Intervention
• Patient Age: 49 YR
• Patient Sex: Female
• Patient Weight: 66 KG