MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US ALTRX NEUT 32IDX54OD; PINNACLE HIP SYSTEM : HIP POLY ACETABULAR LINERS

Model Number	1221-32-054
Medical Device Problem Code	Device Dislodged or Dislocated (2923)
Health Effect - Clinical Codes	Insufficient Information (4580); Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Date of Event	09/10/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.
Event or Problem Description
Patient operated 2017 (b)(6) clinic.Reoperated due to liner disassociation.Doi: 2017, dor: unknown, unknown side.
Additional 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 synthese joint reconstruction, or its employees that the report constitutes an admission that the product, depuy synthese 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.
Additional 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.Corrected: b3 and h6 (patient).
Event or Problem Description
A.Date of event: 2017 c.What is the affected side involved in this event? no information d.Was surgery time extended? if yes, what is the duration of the delay? no delay e.Was the cup available for return? yes f.For reports of disassociation we are required to enter the acetabular cup even if it was not revised.Can you please provide the acetabular cup product / lot information? yes, it has been involved in the first report due to the nature of the reported event, and in accordance with our procedures, we are required to request the following information to assist in the investigation.Please could you let me know if any/none of this information is available: - 1.Radiographs/x-ray films please provide all x-rays relevant to the reported event for example - pre-operative, post primary, pre-revision and intervening time points.Provided in first report 2.Patient demographics the following are the types of patient demographics we require: - - relevant comorbidities, date of implantation, date of revision, operative side, age at the time of the procedure, weight, height, and activity level.2017 3.Implant insertion op notes:- please provide all notes relevant to the reported event for example: - - reason for implant insertion, device labels, surgery report, physiotherapy report, early falls and/or dislocations.No info.4.Implant removal op notes:- please provide all notes relevant to the reported event for example: - - reason for revision, surgeon report and product and lot codes of devices remaining in situ.Liner disassociation, totally loose liner.
Additional 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.
Additional Manufacturer Narrative
Product complaint # (b)(4).Investigation summary examination of the returned device and provided images found evidence to support disassociation of the liner from the cup while implanted.Depuy considers the investigation closed.Should additional info be received, the investigation will be re-opened as necessary.Device history lot a worldwide complaint database search found no additional related reports against the provided product code/lot number combination.Based on the inability to find any additional related reports against the provided product code/lot number combination, it is reasonable to conclude that there are no anomalies with regard to manufacturing or inspection contained in the device history records that would contribute to the reported event.H10 additional narrative:.

• Brand Name: ALTRX NEUT 32IDX54OD
• Common Device Name: 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: kara ditty-bovard ; 700 orthopaedic dr.; warsaw, IN 46581-0988 ; 6107428552
• MDR Report Key: 12539767
• Report Number: 1818910-2021-21227
• Device Sequence Number: 4102866
• Product Code: LPH
• UDI-Device Identifier: 10603295016120
• UDI-Public: 10603295016120
• Combination Product (Y/N): N
• Initial Reporter Country: SW
• PMA/510(K) Number: K072963
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Device Explanted Year: 2021
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date (Section B): 09/10/2021

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
• Operator of Device: Health Professional
• Device Model Number: 1221-32-054
• Device Catalogue Number: 122132054
• Device Lot Number: H45118
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/23/2021
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/10/2021
• Supplement Date Received by Manufacturer: 09/27/2021; 09/23/2021; 10/22/2021; 12/02/2021
• Initial Report FDA Received Date: 09/28/2021
• Supplement Report FDA Received Date: 10/03/2021; 10/05/2021; 10/26/2021; 12/03/2021
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/15/2017
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: ALTRX NEUT 32IDX54OD; UNKNOWN HIP ACETABULAR CUP; UNKNOWN HIP FEMORAL HEAD; ALTRX NEUT 32IDX54OD; UNKNOWN HIP ACETABULAR CUP
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown