MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS, INC. 1818910 PINN MAR +4 10D 28IDX48OD; PINNACLE HIP SYSTEM : HIP POLY ACETABULAR LINERS

Catalog Number	121928148
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	Pain (1994)
Date of Event	06/01/2018
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.Concomitant med products: unknown hip femoral head; pinn mar +4 10d 28idx48od; unknown hip acetabular cup; unknown hip femoral stem.
Event or Problem Description
Customer reported to bfarm: primary implantation of a cementless depuy hip-tep (pinnacle cup / corail stem) left on (b)(6) 2017.Initially inconspicuous post-op course.Patient indicated onset of pain / muscular problem in the left hip since end of (b)(6) 2018.Additional on (b)(6) 2018 occurrence of noise phenomena in the area of the hip tep on the left side.A previous relevant trauma / movement moment is negated by the patient.Thereupon visit at the orthopedic practitioner on (b)(6) 2018 and also on (b)(6) 2018 at our hospital.Radiograph showed decentralisation of hip head of the hip prosthesis without evidence of dislocation.On (b)(6) 2018 revision of hip-tep left.Intraoperatively a dislocation of the inlay from the pinnacle-pressfit cup was obvious - an explanatory correlate for this was not evident.Revision of hip-head and inlay.
Additional Manufacturer Narrative
Product complaint # = > pc-(b)(4).Investigation summary = > investigation summary (insert the complaint description here) no device associated with this report was received for examination.A worldwide lot specific complaint database search, or device history record (dhr) review, was not possible because the required lot code(s) was not provided.The investigation could not draw any conclusions regarding the reported event.Based on the inability to determine a root cause, the need for corrective action was not indicated.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.
Additional 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.
Additional 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 # = > (b)(4).Investigation summary = > a review of complaint databases and manufacturing records did not identify any anomalies.Root cause undetermined.Depuy synthes considers the investigation closed at this time.Should additional information be received, the information will be reviewed and the investigation may 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.
Additional 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.

• Brand Name: PINN MAR +4 10D 28IDX48OD
• Common Device Name: PINNACLE HIP SYSTEM : HIP POLY ACETABULAR LINERS
• Manufacturer (Section D): DEPUY ORTHOPAEDICS, INC. 1818910; 700 orthopaedic drive; warsaw IN 46582 0988
• MDR Report Key: 7793012
• Report Number: 1818910-2018-66989
• Device Sequence Number: 13846363
• Product Code: LPH
• UDI-Device Identifier: 10603295013457
• UDI-Public: 10603295013457
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K001534
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Device Explanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date (Section B): 07/24/2018

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?: No
• Operator of Device: Health Professional
• Device Expiration Date: 05/31/2019
• Device Catalogue Number: 121928148
• Device Lot Number: 542438
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 07/24/2018
• Supplement Date Received by Manufacturer: 09/07/2018; 02/11/2019; 02/11/2019; 03/05/2019
• Initial Report FDA Received Date: 08/17/2018
• Supplement Report FDA Received Date: 09/11/2018; 02/12/2019; 02/28/2019; 03/15/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 27 YR
• Patient Weight: 67