MAUDE Adverse Event Report: DEPUY (IRELAND) 9616671 PINN CER INSERT 36X52OD IDE; HIP ACETABULAR INSERT/LINER

Catalog Number 195085752

Device Problem Noise, Audible (3273)

Patient Problem Pain (1994)

Event Date 11/10/2015

Event Type  Injury  

Manufacturer Narrative

(b)(4).This complaint is still under investigation.Depuy will notify the fda of the results of this investigation once it has been completed.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

Event Description

Patient was revised to address pain and squeaking.Update (b)(6) 2015 clinical report states patient was revised to address pain.

Manufacturer Narrative

Visual examination of the returned devices finds nothing outward to suggest product problem.The patient is considered obese.It is stated in the ceramic essential product information "do not implant in obese patients because overloading the component may lead to fracture or loss of fixation".A search of the complaints databases identified no other similar or related reports against the product/lot code combinations.Medical records were reviewed.It was reported the patient fell several times.Previous review of provided x-rays finds a one mm interface gaps in zones 1, 2, 3 in (b)(6) 2010 as well as an anteverted cup.The investigation can draw no conclusions with the information provided.Product problem has not been identified.Based on the performed investigation, the need for corrective action has not been indicated.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.

Manufacturer Narrative

Added: event/problem description, lot #/expiration date, date received by manufacturer.Corrected: brand name, catalog #.The investigation has been reopened due to receiving part and lot number.Depuy will notify the fda when the investigation is complete.(b)(4).

Event Description

Clinical report states pain when squeaking.Update: 10/26/2012-additional radiographic review received.Update rec'd 06/03/2014 - clinical report states patient continues to have squeaking and grinding that is being treated with percocet, but there has still been no revision.A video clip of the patient demonstrating the squeaking during movement was provided and has been attached.There is no new information that would affect the mdr decision.Update received 7/16/2014.Clinical report received.There is no additional information that would affect the mdr decision.Update received 12/12/2014.Clinical report received.There is no additional information that would affect the mdr decision.Update 11/10/2015: patient was revised to address pain and squeaking.Update 11/10/2015: clinical report states patient was revised to address pain.Update rec'd 12/03/2015 - the patient's medical records were received.Medical records were reviewed for mdr reportability.According to the medical records the patient's pain began after falling several times.At this time there is no new information that would change the existing mdr decision.Update received 12/15/2015.An additional clinical report was received.Report states that patient was experiencing pain and stiffness.Complaint has been updated with the additional harm.

Manufacturer Narrative

Additional narrative: visual examination of the returned devices finds nothing outward to suggest product problem.The patient is considered obese.It is stated in the ceramic essential product information "do not implant in obese patients because overloading the component may lead to fracture or loss of fixation." a search of the complaints databases identified no other similar or related reports against the product/lot code combinations.Medical records were reviewed.It was reported the patient fell several times.Previous review of provided x-rays finds a one mm interface gaps in zones 1, 2, 3 in jan 2010 as well as an anteverted cup.The investigation can draw no conclusions with the information provided.Product problem has not been identified.Based on the performed investigation, the need for corrective action has not been indicated.Depuy considers the investigation closed.Should additional information be received, the information will be reviewed and the investigation will be re-opened as necessary.

• Brand Name: PINN CER INSERT 36X52OD IDE
• Type of Device: HIP ACETABULAR INSERT/LINER
• Manufacturer (Section D): DEPUY (IRELAND) 9616671; loughbeg, ringaskiddy co.; cork, munster ; EI
• Manufacturer (Section G): DEPUY (IRELAND) 9616671; loughbeg, ringaskiddy co.; cork, munster ; EI
• Manufacturer Contact: chad gibson ; 700 orthopaedic drive; warsaw, IN 46581 ; 5743725905
• MDR Report Key: 5257038
• MDR Text Key: 32358990
• Report Number: 1818910-2015-36036
• Device Sequence Number: 1
• Product Code: MRA
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: PP070026
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,health profession
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 11/10/2015

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
• Device Operator: Health Professional
• Device Expiration Date: 02/21/2011
• Device Catalogue Number: 195085752
• Device Lot Number: 2107274
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/02/2015
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/10/2015
• Initial Date FDA Received: 12/01/2015
• Supplement Dates Manufacturer Received: Not provided; Not provided; Not provided
• Supplement Dates FDA Received: 01/07/2016; 03/23/2016; 05/18/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/21/2006
• 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
• Patient Outcome(s): Required Intervention
• Patient Age: 66 YR
• Patient Weight: 70