MAUDE Adverse Event Report: ZIMMER GMBH DUROM US ACET CMPNT 54/48 N; DUROM ACETABULAR COMPONENT AND METASUL LDH LARGE DIAMETER HEADS

Model Number N/A

Device Problems Loosening of Implant Not Related to Bone-Ingrowth (4002); Migration (4003)

Patient Problems Pain (1994); Inadequate Osseointegration (2646); Metal Related Pathology (4530); Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 02/10/2021

Event Type  Injury  

Manufacturer Narrative

This product is manufactured by zimmer biomet (b)(4) and is not cleared or distributed in the u.S.However, this report is being submitted as zimmer biomet (b)(4) manufactures a similar device that is cleared or distributed in the united states.Concomitant medical product: metasul ldh, head, 48, code n, taper 18/20; catalog#: 01.00181.480; lot#: 2353697.Therapy date: (b)(6) 2021.The manufacturer did not receive devices, x-rays, or other source documents for review.Where lot numbers were received for the devices, the device history records were reviewed and found to be conforming.While a cause for this specific event cannot be ascertained from the information provided, the common clinical presentation and the date of the original implantation suggest that this case is related to the issues for which zimmer implemented a notification in july 2008.Should additional information become available and / or the device(s) be returned for evaluation and an investigation result becomes available, that changes this assessment, an amended medical device report will be submitted.The need for further corrective measures is not indicated at this time.(b)(4).

Event Description

Patient was implanted with a durom cup on an unknown date in 2006 on the right side and underwent a revision surgery due to loosening.

Event Description

No change to previously reported event.

Manufacturer Narrative

This follow-up report is being submitted to relay corrected and additional information.Additional: h2, h6 correction: b4, g4, g7, h10.Complaint investigation: - dhr review: the device history records were reviewed and found to be conforming.- review of event description: patient was implanted in 2006 and underwent revision upon surgeon's suggestion.It was noticed during the revision that implant loosened.- other information & sources: review of the complaint relevant documents did not lead to new information regarding the reported event.- no further due diligence required as all required information to support the conclusion is available/was already requested.Conclusion no further investigation required as this issue is known and addressed in (b)(4).(error pattern: potential early revision of the acetabular component due to loosening, implant migration or unresolved pain, higher ion release).At least one of these error patterns is observed in this event.Should any additional information that changes the assessment become available to us, or any extra demand be requested, we will re-evaluate the case.The need for corrective measures is not indicated and zimmer gmbh considers this case as closed.Zimmer biomet¿s reference number of this file is (b)(4).

Event Description

Event update: it was now reported that the patient was revised due to pain, disability, elevated cocr, loosening.Note: this new information does not change the outcome of the investigation.

Manufacturer Narrative

This follow-up report is being submitted to relay updated event information.Additional: h2, h6 correction: b4, b5, g3, g6, h10 event update: it was now reported that the patient was revised due to pain, disability, elevated cocr, loosening.Note: this new information does not change the outcome of the investigation.Complaint investigation - dhr review: the device history records were reviewed and found to be conforming.- review of event description: patient was implanted in 2006 and underwent revision upon surgeon's suggestion.It was noticed during the revision that implant loosened.- other information & sources: review of the complaint relevant documents did not lead to new information regarding the reported event.- no further due diligence required as all required information to support the conclusion is available/was already requested.Conclusion no further investigation required as this issue is known and addressed in wt123080 (error pattern: potential early revision of the acetabular component due to loosening, implant migration or unresolved pain, higher ion release).At least one of these error patterns is observed in this event.Should any additional information that changes the assessment become available to us, or any extra demand be requested, we will re-evaluate the case.The need for corrective measures is not indicated and zimmer gmbh considers this case as closed.Zimmer biomet¿s reference number of this file is (b)(4).

• Brand Name: DUROM US ACET CMPNT 54/48 N
• Type of Device: DUROM ACETABULAR COMPONENT AND METASUL LDH LARGE DIAMETER HEADS
• Manufacturer (Section D): ZIMMER GMBH; sulzer allee 8; sulzer industrie park; winterthur 8404 ; SZ 8404
• MDR Report Key: 11526975
• MDR Text Key: 240984535
• Report Number: 0009613350-2021-00132
• Device Sequence Number: 1
• Product Code: KWA
• Combination Product (y/n): N
• PMA/PMN Number: K053536
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Remedial Action: Notification
• Type of Report: Initial,Followup,Followup
• Report Date: 04/06/2021

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
• Device Operator: Lay User/Patient
• Device Expiration Date: 09/30/2011
• Device Model Number: N/A
• Device Catalogue Number: 01.00214.154
• Device Lot Number: 2341988
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 03/09/2021
• Initial Date FDA Received: 03/19/2021
• Supplement Dates Manufacturer Received: 03/12/2021; 03/30/2021
• Supplement Dates FDA Received: 03/31/2021; 04/06/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Treatment: SEE H10 NARRATIVE
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Weight: 104