MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US PINN MAR +4 NEUT 36IDX60OD; HIP ACETABULAR INSERT/LINER

Catalog Number	121936460
Medical Device Problem Code	Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	Joint Dislocation (2374)
Date of Event	11/22/2016
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
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
Description of the adverse event surgical site dislocation - initial.Update received 12/6/2016.Clinical report was received stating that the patient has had a posterior dislocation.The dislocation was treated with closed reduction.Complaint was updated on 12/15/2016.Update rec'd 01/31/2017 - the patient's medical records were received.Medical records were reviewed for mdr reportability.There is no new information that would change the existing mdr decision.The complaint was updated on: 02/08/2017.Update 01may2017- clinical der received that the patient was revised to address dislocation of right hip.This complaint was created on 29jun2017.Update 5-1-2017: revision of right total hip on (b)(6)2017 for dislocation.Depuy head and liner were revised.Head and liner are now reportable.Updated 7-5-2017.
Additional Manufacturer Narrative
Product complaint # = > pc-000101629 investigation summary = > no device associated with this report was received for examination.The information received will be retained for potential series investigations if triggered by trend analysis, post market surveillance, or other events within the quality system.Depuy considers the investigation closed.Should additional information be received, the information will be reviewed and the investigation will be re-opened as necessary.Device history lot = > null device history batch = > null device history review = > null 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
Complaint description: description of the adverse event surgical site dislocation - initial **update received 12/6/16.Clinical report was received stating that the patient has had a posterior dislocation.The dislocation was treated with closed reduction.*complaint was updated on 12/15/16 update rec'd 01/31/2017 - the patient's medical records were received.Medical records were reviewed for mdr reportability.There is no new information that would change the existing mdr decision.The complaint was updated on: 02/08/2017 update 01may2017- clinical der received that the patient was revised to address dislocation of right hip.This complaint was created on (b)(6) 2017.Update 5-1-2017: revision of right total hip on (b)(6) 2017 for dislocation.Depuy head and liner were revised.Head and liner are now reportable.Updated 7-5-2017./ | investigation method: - without the physical complaint sample(s) associated with this report, it was not possible to determine if the device(s) failed to meet specification(s) at the time it was released for distribution.- the device(s) associated with this event were used in the treatment of the patient as prescribed by the presiding surgeon.- from the event information received, it was not possible to determine the relationship of the device to the reported event.Examination of the reported devices was not possible as they were not returned.A search of the complaints databases finds no other reports against the product and lot code combinations since their release to distribution.The investigation can draw no conclusion with the information provided.Based on the inability to find any other reported incidents against the provided product and lot code combinations, it is not unreasonable to conclude that there are no anomalies with regard to manufacturing, inspection or sterilization contained in the device history records that would contribute to the reported event.----------- no implant fracture or disassociation noted.In the 11/17/2016 view, the right hip construct is dislocated.In the (b)(6) 2016 and (b)(6) 2016 views the acetabular cup appears more vertical than would be recommended by the surgical technique.No changes to previous investigation / | investigation summary: description of the adverse event surgical site dislocation - initial **update received 12/6/16.Clinical report was received stating that the patient has had a posterior dislocation.The dislocation was treated with closed reduction.*complaint was updated on 12/15/16 examination of the reported devices was not possible as they were not returned.A search of the complaints databases finds no other reports against the product and lot code combinations since their release to distribution.The investigation can draw no conclusion with the information provided.Based on the inability to determine root cause, the need for corrective action has not been indicated.------- update rec'd 01/31/2017 - the patient's medical records were received.Medical records were reviewed for mdr reportability.There is no new information that would change the existing mdr decision.The complaint was updated on: 02/08/2017 examination of the reported devices was not possible as they were not returned.A search of the complaints databases finds no other related reports against the product and lot code combinations since their release to distribution.X-rays were reviewed and confirm the reported dislocation.Acetabular placement seems to be more vertical than what would be considered optimal per the surgical technique.The investigation can draw no conclusion with the information provided.Based on the inability to determine root cause, the need for corrective action has not been indicated.

• Brand Name: PINN MAR +4 NEUT 36IDX60OD
• Common Device Name: HIP ACETABULAR INSERT/LINER
• Manufacturer (Section D): DEPUY ORTHOPAEDICS INC US; 700 orthopaedic drive; warsaw IN 46581 0988
• MDR Report Key: 6700204
• Report Number: 1818910-2017-20843
• Device Sequence Number: 11278959
• Product Code: LPH
• UDI-Device Identifier: 10603295014744
• UDI-Public: 10603295014744
• Combination Product (Y/N): N
• Initial Reporter State: CO
• Initial Reporter Country: US
• PMA/510(K) Number: K010171
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2005
• Device Explanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: health professional,other,stu
• Initial Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 12/06/2016

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 Catalogue Number: 121936460
• Device Lot Number: X82M81
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 05/01/2017
• Supplement Date Received by Manufacturer: 07/18/2018
• Initial Report FDA Received Date: 07/11/2017
• Supplement Report FDA Received Date: 07/31/2018
• 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 Weight: 90