MAUDE Adverse Event Report: ZIMMER SWITZERLAND MANUFACTURING GMBH ZIMMER MMC, CUP, UNCEMENTED, 56 MM/48 MM, CODE N; ZIMMER MMC CUP

Model Number N/A

Device Problems Fracture (1260); Material Integrity Problem (2978); Appropriate Term/Code Not Available (3191); Patient Device Interaction Problem (4001)

Patient Problems Cyst(s) (1800); Failure of Implant (1924); Pain (1994); Depression (2361); Osteolysis (2377); Metal Related Pathology (4530); Swelling/ Edema (4577)

Event Date 10/14/2020

Event Type  Injury  

Manufacturer Narrative

This product is manufactured by zimmer biomet winterthur and is not cleared or distributed in the u.S.However, this report is being submitted as zimmer biomet winterthur manufactures a similar device that is cleared or distributed in the united states.Medical products: metasul ldh, head adapter, s, -4, taper 12/14-18/20; catalog#: 01.00185.145; lot#: 2565568.Metasul ldh, head, 48, code n, taper 18/20; catalog#: 01.00181.480; lot#: 2551767.Femoral stem beaded fullcoat 12/14 neck taper std.Body std.Offset size 11 11 mm distal dia.160 mm length; catalog #: 00-7843-011-06; lot#: 61710257.Therapy date: (b)(6) 2020.The manufacturer received other source documents for review.The manufacturer did not receive the device for investigation.Where lot numbers were received for the devices, the device history records were reviewed and found to be conforming.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

Patient underwent an initial right hip resurfacing which was converted into a right tha due to femoral neck fracture.The patient showed no symptoms after this until he presented with pain, swelling, elevated metal ion levels and osteolysis and hence underwent a second revision surgery.During the second revision surgery a large metallosis fluid collection in the deep subcutaneous tissue, pseudotumor, moderate trunionosis around the base of the trunnion and significant metallosis within the acetabulum and cavitary osteolytic defects were reported.

Manufacturer Narrative

This follow-up report is being submitted to relay corrected and additional information.Additional: h2, h6 correction: b4, g3, g6, h10.Event description: it was reported that the patient underwent an initial right hip resurfacing on (b)(6), 2012 which was converted into a right tha due to femoral neck fracture on (b)(6) 2012.The patient showed no symptoms after this until he presented with pain, swelling, elevated metal ion levels and osteolysis and hence underwent a second revision surgery on (b)(6) 2020.Review of received data: due diligence: no further due diligence required as all required information to support the conclusion is available or was already requested.Mri report: review of the received report identified small fluid collections; however, no definitive diagnosis could be determined.Surgical report: review of the received report by a health care professional identified that the patient experienced pain, swelling, elevated metal ions, and osteolysis around the acetabular and femoral components.Signs of metallosis were detected in the subcutaneous tissue though the distal it band and within the acetabulum and cavitary osteolytic defects.There was an underlying pseudotumor by the distal it band.The base of the trunnion had moderate trunnionosis.Product evaluation: no product was returned; therefore, visual and dimensional evaluation could not be performed.Review of product documentation: device purpose: all involved devices are intended for treatment.Product compatibility: the product combination was approved by zimmer biomet.Dhr review: review of the device history records identified the following deviations and/or anomalies: ncr (b)(4).Ncr(s): no ncr with a potential correlation to the reported event was found.Conclusion: it was reported that the patient underwent an initial right hip resurfacing on (b)(6), 2012 which was converted into a right tha due to femoral neck fracture on (b)(6) 2012.The patient showed no symptoms after this until he presented with pain, swelling, elevated metal ion levels and osteolysis and hence underwent a second revision surgery on (b)(6), 2020.Based on the investigation the reported event can be confirmed.The quality records show that all specified characteristics have met the specifications valid at the time of production.Therefore, the investigation did not identify a nonconformance or a complaint out of box (coob).Based on the given information and the results of the investigation, we were not able to identify a specific root cause for this issue.The need for corrective measures is not indicated and zimmer switzerland manufacturing gmbh considers this case as closed.Zimmer biomet¿s reference number of this file is (b)(4).

Event Description

No change to previously reported event.

Manufacturer Narrative

(b)(4).This follow-up report is being submitted to relay additional information.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.

Event Description

No additional information on the reported event.

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 information.No products were returned; visual and dimensional evaluations could not be performed.Review of the device history records identified no deviations or anomalies during manufacturing related to the reported event.Devices are used for treatment.Medical records were provided and reviewed by a health care professional.Review of the available records identified the following: the patient underwent a right hip resurfacing procedure and was converted to a total hip.Zimmer biomet components were implanted without complications.The patient underwent a revision procedure due to failed hip arthroplasty.The patient presented with pain and swelling.Metal ions in the blood were elevated and there was osteolysis around the acetabular and femoral implants.There was a large metallosis fluid collection in the deep subq tissue through the distal it band with underlying pseudotumor.Moderate trunnionosis was noted at the base of the trunnion.The cup, liner, and head were replaced with competitor's products.No other finding/complication related to the reported event was noted.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.Multiple mdr reports were filed for this event, please see associated reports: 0009613350-2021-00263, 0009613350-2021-00269.

• Brand Name: ZIMMER MMC, CUP, UNCEMENTED, 56 MM/48 MM, CODE N
• Type of Device: ZIMMER MMC CUP
• 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: 11957648
• MDR Text Key: 255054907
• Report Number: 0009613350-2021-00267
• Device Sequence Number: 1
• Product Code: KWA
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K091003
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Consumer,Health Professional
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 10/04/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/08/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 07/31/2020
• Device Model Number: N/A
• Device Catalogue Number: 01.00634.056
• Device Lot Number: 2564524
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 09/29/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/11/2010
• 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 Age: 63 YR
• Patient Sex: Male
• Patient Weight: 73 KG