MAUDE Adverse Event Report: ZIMMER SWITZERLAND MANUFACTURING GMBH DUROM US ACET CMPNT 58/52 R; DUROM ACETABULAR COMPONENT AND METASUL LDH LARGE DIAMETER HEADS

Model Number N/A

Device Problems Adverse Event Without Identified Device or Use Problem (2993); Migration (4003)

Patient Problems Failure of Implant (1924); Inadequate Osseointegration (2646); Metal Related Pathology (4530)

Event Type  Injury  

Event Description

It was reported that, legal received the following new claim.No additional information is available.Patient outcome - revision due to loosening.

Manufacturer Narrative

Concomitant medical product: metasul® ldh®, head, 52, code r, taper 18/20, catalog#: 01.00181.520, lot#: 2353710.The manufacturer did not receive x-rays, or other source documents for review.The manufacturer did not receive the device for investigation.The lot number of the device was received.The device history records will be reviewed during investigation.A cause for this specific event cannot be ascertained from the information provided.As soon as supplemental information becomes available an updated report will be submitted.Zimmer biomet¿s reference number of this file is (b)(4).

Manufacturer Narrative

This follow-up report is being submitted to relay additional and/or corrected information.Implant surgery in 2008.A cause for this specific event cannot be ascertained from the information provided.As soon as supplemental information becomes available an updated report will be submitted.Zimmer biomet¿s reference number of this file is (b)(4).

Event Description

No change to previously reported event.

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.No product was returned or pictures provided; visual and dimensional evaluations could not be performed.Review of the device history record identified no deviations or anomalies during manufacturing.Device is used for treatment.Medical records were not provided.The complaint cannot be confirmed.A definitive root cause cannot be determined.If any further information is found which would change or alter any conclusions or information, a supplemental report will be filed accordingly.Zimmer biomet will continue to monitor for trends.

Event Description

No further event information available at the time of this report.

Event Description

No further event information available at the time of this report.

Manufacturer Narrative

(b)(4).This follow-up report is being submitted to relay additional and/or corrected information.If any further information is found which would change or alter any conclusions or information, a supplemental report will be filed accordingly.Zimmer biomet will continue to monitor for trends.

Event Description

It was reported that the patient underwent revision surgery due to elevated cocr, loosening, and migration.

Manufacturer Narrative

(b)(4).This follow-up report is being submitted to relay additional information.The following sections were updated: a2, a3,b4, b5, g3, g6, h6, h10.Review of the device history record identified no deviations or anomalies during manufacturing.Visual examination of the provided pictures identified little or no bone ingrowth into the surface of the external surface of the metasul durom acetabular component, the photographs of the internal surface shows marks and stains but due to the highly polished nature of this product it difficult to assess fully via photographs.Operative report was provided, and a review of the available records identified the following: interoperative findings: interoperative examination of the patient's left hip did show a large blood-tinged effusion.There was no evidence purulence or overt synovitis.There was no evidence of metallosis.Preoperative fluoroscopic images of the hip showed displacement of the acetabular component in an inferomedial position, which was a change from the last radiograph obtained in the office.The stem appeared well fixed.The acetabular component was grossly loose.The patient's abductor muscles appeared intact, and there was abundant scar tissue about the hip.The patient also had a leg length inequality with the left leg being shorter than the right due to the displaced acetabular component.A definitive root cause cannot be determined.If any further information is found which would change or alter any conclusions or information, a supplemental will be filed accordingly.Zimmer biomet will continue to monitor for trends.

• Brand Name: DUROM US ACET CMPNT 58/52 R
• Type of Device: DUROM ACETABULAR COMPONENT AND METASUL LDH LARGE DIAMETER HEADS
• Manufacturer (Section D): ZIMMER SWITZERLAND MANUFACTURING GMBH; sulzer allee 8; sulzer industrie park; winterthur 8404 ; SZ 8404
• Manufacturer (Section G): ZIMMER SWITZERLAND MANUFACTURING GMBH; sulzer allee 8; sulzer industrie park; winterthur 8404 ; SZ 8404
• Manufacturer Contact: christina arnt ; 56 e. bell dr.; warsaw, IN 46582 ; 5745273773
• MDR Report Key: 14307962
• MDR Text Key: 290926545
• Report Number: 0009613350-2022-00269
• Device Sequence Number: 1
• Product Code: KWA
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K053536
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date: 12/06/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/06/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 08/15/2011
• Device Model Number: N/A
• Device Catalogue Number: 01.00214.158
• Device Lot Number: 2338973
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 12/05/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/03/2006
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Treatment: SEE H10 NARRATIVE.
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Sex: Male