MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS, INC. 1818910 PINN MAR +4 10D 36IDX52OD; PINNACLE HIP SYSTEM : HIP POLY ACETABULAR LINERS

Model Number 1219-36-152

Device Problems Material Disintegration (1177); Device Dislodged or Dislocated (2923); Naturally Worn (2988); Separation Problem (4043)

Patient Problems Pain (1994); Joint Dislocation (2374); No Code Available (3191); Joint Laxity (4526); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Date 12/21/2018

Event Type  Injury  

Manufacturer Narrative

Product complaint # (b)(4).If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

Event Description

After 3.5 years after implantation the patient treated with pain in hip joint.In x-rays was identified instability of hip, namely the displacement of the head of implant, which indicated the absence / wear of the liner.It was decided to revise the patient intraoperatively, the liner was missing and the cup was out of joint.

Manufacturer Narrative

Product complaint #: (b)(4).If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

Manufacturer Narrative

(b)(4).If information is obtained that was not available for the initial medwatch, a follow-up medwatch, a follow-up medwatch will be filed as appropriate.

Manufacturer Narrative

Product complaint # (b)(4).Depuy synthes is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on information which depuy synthes has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy synthes or its employees that the report constitutes an admission that the device, depuy synthes, or its employees caused or contributed to the potential event described in this report. .

Manufacturer Narrative

Depuy synthes is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on information which depuy synthes has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy synthes or its employees that the report constitutes an admission that the device, depuy synthes, or its employees caused or contributed to the potential event described in this report.Product complaint #
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> (b)(4).Investigation summary
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> no device associated with this report was received for examination.Depuy considers the investigation closed at this time.Should additional information be received, the information will be reviewed and the investigation will be re-opened as necessary.If information is obtained that was not available for the initial medwatch , a follow-up medwatch, a follow-up medwatch will be filed as appropriate.

Manufacturer Narrative

Product complaint #: (b)(4).Depuy synthes is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on information which depuy synthes has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy synthes or its employees that the report constitutes an admission that the device, 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 medwatch, a follow-up medwatch 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 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: no device associated with this report was received for examination.Depuy considers the investigation closed at this time.Should additional information be received, the information will be reviewed and the investigation will be re-opened as necessary.Device history lot: null,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.H6 clinical code: appropriate term / code not available (e2402) is used to capture unspecified musculoskeletal problem (e1635).

• Brand Name: PINN MAR +4 10D 36IDX52OD
• Type of Device: PINNACLE HIP SYSTEM : HIP POLY ACETABULAR LINERS
• Manufacturer (Section D): DEPUY ORTHOPAEDICS, INC. 1818910; 700 orthopaedic drive; warsaw IN 46582 0988
• MDR Report Key: 8264599
• MDR Text Key: 133691986
• Report Number: 1818910-2019-81620
• Device Sequence Number: 1
• Product Code: LPH
• UDI-Device Identifier: 10603295014577
• UDI-Public: 10603295014577
• Combination Product (y/n): N
• PMA/PMN Number: K033273
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,other,user facility
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date: 12/25/2018

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 Expiration Date: 04/30/2019
• Device Model Number: 1219-36-152
• Device Catalogue Number: 121936152
• Device Lot Number: 527421
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/09/2021
• Initial Date Manufacturer Received: 12/25/2018
• Initial Date FDA Received: 01/21/2019
• Supplement Dates Manufacturer Received: 12/25/2018; 01/30/2019; 01/21/2019; 01/21/2019; 02/22/2019; 09/09/2021; 10/20/2021
• Supplement Dates FDA Received: 01/24/2019; 02/13/2019; 02/18/2019; 02/20/2019; 03/15/2019; 09/17/2021; 10/21/2021
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention